Method for performing a coronary artery bypass graft procedure

ABSTRACT

A method for performing a coronary artery bypass graft procedure on a patient to connect a bypass vessel to a target vessel includes the steps of creating an opening in the patient that communicates with the thoracic cavity of the patient; providing a bypass vessel having a lumen and at least one free end; passing the free end of the bypass vessel from the thoracic cavity through the opening to a position outside the body of the patient; attaching a connector to the free end of bypass vessel while the free end of the bypass vessel is outside the body of the patient; passing the free end of the bypass vessel from the position outside the body of the patient through the opening and into the thoracic cavity; and connecting the free end of the bypass vessel to a target vessel with the connector.

FIELD OF THE INVENTION

The present invention relates generally to apparatus and methods forperforming a vascular anastomosis. More particularly, the presentinvention relates to a vascular anastomosis apparatus for joining agraft vessel, such as a coronary bypass graft, to the sidewall of anexisting vessel, such as a coronary artery.

BACKGROUND OF THE INVENTION

Anastomosis is the surgical joining of tissues of tubular structureshaving a lumen, such as blood vessels, to create communication betweenthe lumina of the structures. Anastomoses are employed in, for example,vascular surgery, for the purpose of creating or restoring blood flowpathways. One example of this is coronary artery bypass surgery (CABG),a procedure designed to restore blood flow to portions of the heartwhose blood supply has been reduced by occlusion or stenosis of at leastone coronary artery.

One method for CABG involves harvesting a saphenous vein from thepatient's body, or using an artificial conduit, and connecting the veinor conduit to the occluded or stenosed artery as a bypass graft fromanother artery, such as the aorta, downstream of the occlusion orstenosis. In this method, the bypass graft must be attached to the sidesof existing arteries at both the proximal and distal ends of the graftby proximal and distal anastomoses.

An alternative method involves rerouting a less important artery fromits normal location to another location downstream of the occlusion orstenosis. In this method, only a distal anastomosis between the distalend of the graft and the side of an existing artery may be required tocomplete the procedure.

One method for performing vascular anastomosis is by hand suturing. Thisis a time-consuming and difficult task requiring a high degree ofsurgical skill to perform successfully due to the considerableperfection, required to achieve reliable and consistent functionality.The procedure poses consequently a relatively high risk to the patient,because the overall outcome is so much dependent on this functionality.Not only does the surgeon have to provide a leak-free connection ofvessels so small, that optical magnification is routinely used, but alsothe anastomosis must provide a smooth, open flow path for the blood. Inthis method, there is frequently a need for additional suturing of theanastomosis to close any leaks that are detected. Besides the requiredprecision, the time-consuming nature of a hand-sutured anastomosis is ofspecial concern.

Since in CABG, anastomoses have to be constructed on a constantlymoving, extremely vital organ, the operative technique needs a carefulsetup. In the majority of cases, the patient is typically supported oncardiopulmonary bypass (CPB) for most of the surgical procedure. Theheart can then be safely stopped by cross-clamping the aorta to isolateit from the systemic circulation and perfusing it with a cardioplegiasolution in order to offer an immobile and stable area for precisesuturing. CPB itself is a traumatic procedure that may result inpost-surgical complications, which are, among others, related to CPBduration. In recent years, alternative techniques have been developed tocompletely avoid CPB, by hand-suturing anastomoses on the beating,working heart using epicardial stabilizers (as described, for example inU.S. Pat. No. 5,836,311) that immobilize only a small area of the heart.However, practice has shown that the delicate procedure of hand-suturingthe anastomosis may become even more difficult under such conditions,thus potentially having a negative impact on overall quality, even inexperienced hands. Therefore, it is desirable to reduce the complexityand duration of the procedure by expediting the anastomosis procedurewithout reducing the quality or effectiveness of the anastomosis.

In order to reduce the difficulty of creating a vascular anastomosisduring CABG, it is desirable to provide a rapid means for making areliable anastomosis between a bypass graft, vein or artery and thenative blood vessel. A first approach to expediting and improving theanastomosis procedure is through the use of stapling technology.However, the instruments for stapling other organs are not easilyadaptable for use in creating a vascular anastomosis, and the small sizeof coronary arties raises additional technical difficulties. Variousattempts have been made to provide such vascular stapling devices, suchas in U.S. Pat. Nos. 4,350,160 and 5,234,447. Other approaches to thisproblem are found in, for example, U.S. Pat. Nos. 4,366,819; 4,368,736;4,624,257; 4,917,090 and 4,917,091.

More recently, specialized devices for creating a vascular anastomosishave been described in, for example, U.S. Pat. Nos. 5,695,504;6,074,416; 5,931,842; 5,976,178; 6,066,148; 5,833,698; 5,707,380;6,485,496 and U.S. Patent Publication No. US2002/0183769.

There remains a need for an anastomosis device which performs a suitablevascular anastomosis in a reliable manner and as quickly as possible.

SUMMARY OF THE INVENTION

The present invention provides an anastomosis system for quickly andreliably performing a vascular anastomosis. The anastomosis systemincludes an anastomosis connector and an applicator. The connector is atubular or annular device that is adapted to be expanded and permanentlydeformed to provide the anastomosis. The applicator provides a specialsequence of movements to cause expansion and deformation of theconnector. The applicator includes an expander, an expandable outer tubeand an expandable inner tube located at least partially within a lumenof the expandable outer tube. The applicator also includes a mechanismfor causing movement of the expander to thereby expand the inner andouter tubes of the applicator. The system is useful in providing avascular anastomosis between a vascular graft and a natural blood vesselin CABG surgery, but may be useful for other applications as well. Thepresent invention also provides an anastomosis method for quickly andreliably performing a vascular anastomosis.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a directly actuated applicator.

FIG. 2 is a perspective view of a remotely actuated applicator, whichpermits remote operation of the applicator.

FIG. 3 is a perspective view of one embodiment of a connector inaccordance with the present invention.

FIG. 4 is a side view of the connector of FIG. 3.

FIG. 5 is an end view of the connector of FIG. 3.

FIG. 6 is a perspective view of the distal end of an applicator inaccordance with the present invention, in the insertion position.

FIG. 7 is a perspective view of the distal end of the applicator of FIG.6 in an expanded position.

FIG. 8A is a partial cross-sectional view of an applicator for deployingindividual staples or clips to make an anastomotic connection.

FIG. 8B is a perspective view of the distal end of the outer tube of theapplicator of FIG. 8A.

FIG. 8C is an end view of the outer tube of the applicator of FIG. 8A ina first position.

FIG. 8D is an end view of the outer tube of the applicator of FIG. 8A ina second, expanded position.

FIGS. 8E and 8F are top and side cross-sectional views of the staples orclips of FIG. 8A deployed at the location of an anastomosis.

FIG. 9 is a perspective view of the outer tube of the applicator of FIG.6.

FIG. 10 is a cross-sectional view of the outer tube taken along the lineX-X of FIG. 9.

FIG. 11 is an end view of the outer tube of FIG. 9.

FIG. 12 is a cross-sectional view of the outer tube of FIGS. 9-11 takenalong the line XII-XII of FIG. 11.

FIG. 13 is a detailed end view of the outer tube of FIG. 9.

FIG. 14 is an end view of the proximal end of the inner tube of theapplicator of FIG. 6.

FIG. 15 is a cross-sectional view of the inner tube taken along the lineXV-XV of FIG. 14.

FIG. 16 is a detail view of the area XVI shown in FIG. 15.

FIG. 17 is an end view of the distal end of the inner tube of FIG. 15.

FIG. 18A shows a special pattern for the slits between the fingers ofthe outer tube to provide a keying mechanism.

FIG. 18B shows a perspective view of two fingers of the outer tube witha keying mechanism formed by the slits of FIG. 18A.

FIG. 18C shows a top view of portions of the inner and outer tubesformed with an alternative embodiment of a keying mechanism.

FIG. 18D is a cross-sectional view of portions of the inner and outertubes of FIG. 18C showing the inner and outer tubes keyed together bythe keying mechanism.

FIG. 19 is a perspective view of an expander in accordance with thepresent invention.

FIG. 20 is a perspective view of the distal portion of the expander rodor tube of one embodiment of the present invention with the expanderhead removed.

FIG. 21 is a perspective view of the distal portion of the expander rodor tube of FIG. 20 including the expander head attached to the expanderrod or tube.

FIG. 22 is a perspective view of the distal portion of the expander rodor tube of FIG. 21 further including the shoe attached to the expanderhead.

FIG. 23 is a perspective view of the distal end of the expander showingan alternative embodiment for attaching the shoe to the device.

FIG. 24 is a perspective view of the distal end of the expander showingan alternative embodiment of the expander head.

FIG. 25 is a perspective view of the distal end of the expander showingan alternative embodiment of the expander tube.

FIG. 26A is a cross sectional view of another embodiment of an expanderin accordance with the invention.

FIG. 26B is a perspective view of the underside of the shoe of FIGS.22-25.

FIG. 26C is a perspective view of the device of FIGS. 23-26B in theexpanded position.

FIG. 26D is a perspective view of the distal end of the applicator ofFIG. 26C with the attached shoe in removal position.

FIG. 27A is a perspective view of another embodiment of an expander inaccordance with the present invention.

FIG. 27B is a perspective view of the device of FIG. 27A with the shoeremoved.

FIG. 27C is a side view of the expander of FIGS. 27A-27B.

FIG. 27D is a cross-sectional view of the expander of FIGS. 27A-27C.

FIG. 27E is a perspective view of the expander of FIGS. 27A-27D in theinsertion position.

FIG. 27F is a perspective view of the expander of FIGS. 27A-27E in theexpanded position.

FIG. 28A is a perspective view of an alternative embodiment of anexpander in accordance with the present invention.

FIG. 28B is another perspective view of the expander of FIG. 28A.

FIG. 28C is a cross-sectional view of the expander of FIGS. 28A-28B.

FIG. 28D is a perspective view of the underside of the shoe shown inFIGS. 28A-28C.

FIG. 28E is a perspective view of the top of the shoe shown in FIGS.28A-28D.

FIG. 28F is a perspective view of the expander head of the expandershown in FIGS. 28A-28C.

FIG. 28G is another perspective view of the expander head of FIG. 28F.

FIGS. 29A-29C show perspective views of an alternative embodiment of anexpander designed for oval or elliptical anastomoses.

FIG. 30A is a perspective view of a dual-cam actuator in accordance withthe present invention.

FIG. 30B is a perspective view of one side of the dual-cam actuator ofFIG. 30A with the housing removed.

FIG. 30C is a perspective view of opposite side of the dual-cam actuatorof FIG. 30B with the housing removed.

FIG. 31 is a partial cutaway view of an alternative embodiment of adual-cam applicator.

FIG. 32 is a perspective view of a portion of the applicator of FIG. 31showing details not shown in FIG. 31.

FIGS. 33A-33C are partial cutaway views showing the movements of theapplicator of FIG. 31.

FIG. 34 is a perspective view of the cam of the applicator of FIG. 31.

FIG. 35 is a side view of the left face of the cam of FIG. 34.

FIG. 36 is a cross sectional view of the cam of FIG. 35 along the lineXXXVI-XXXVI of FIG. 35.

FIG. 37 is a side view of the right face of the cam of FIG. 34.

FIG. 38 is a cutaway view of a hydraulic actuator for an applicator inaccordance with the present invention.

FIGS. 39A-39C are three cutaway views showing the movements of anactuator pulled by a cable in accordance with the present invention.

FIGS. 40A-40C are three cutaway views showing the movements of adual-spring actuator which uses a cam and a pull cable in accordancewith the present invention.

FIG. 41 is a cutaway view of an alternative embodiment of a dual-springactuator.

FIGS. 42A-42B show details of portions of the dual spring actuator ofFIG. 41.

FIGS. 43A-43D show the movements of the dual spring actuator of FIG. 41.

FIG. 44 is cross-sectional view of an alternative embodiment of adual-spring actuator.

FIG. 45 is a cutaway view of a single-spring, single-cam actuator inaccordance with the present invention.

FIGS. 46A-46D are four cutaway views showing the movements of oneembodiment of an actuator which pulls against a spring in accordancewith the present invention.

FIGS. 47A-47C are three cutaway views showing the movements of anotherembodiment of an actuator which employs hinged arms in accordance withthe present invention.

FIGS. 48A-48C are three cutaway views showing the movements of anembodiment of an actuator which employs a hinged arm in accordance withthe present invention.

FIGS. 49A-49D are four cutaway views showing the movements of anembodiment of an actuator which pulls a cable in accordance with thepresent invention.

FIGS. 50A-50C are three cutaway views showing the movements of acam-operated actuator in accordance with the present invention.

FIGS. 51A-51D are four cutaway views showing the movements of anotherembodiment of a cable-pulling actuator in accordance with the presentinvention.

FIGS. 52A-52C are perspective views of one embodiment of a handleportion of the actuator of either of FIGS. 1-2.

FIG. 53 is another perspective view of the handle portion of FIGS.52A-52B with the side cover of the housing removed to expose some of theinternal parts.

FIG. 54 is a close up view of the area LIV of FIG. 53.

FIGS. 55A-55B depict an isometric view of an alternative embodiment of asqueeze and release actuator in accordance with the invention.

FIGS. 56A-56E depict the internal parts of the actuator of FIGS. 55A-55CFIGS. 57A-57D depict the movement sequence of the actuator of FIGS.55A-56E.

FIG. 58 depicts an embodiment of a single squeeze actuator in accordancewith the invention.

FIGS. 59-62 depict a pseudo end-to-side anastomosis procedure employingan anastomosis device in accordance with the present invention.

FIG. 63A shows a side view of the applicator with nosepiece inside thegraft vessel in a first position.

FIG. 63B shows a side view of the applicator with nosepiece penetratingthe graft vessel in a second position.

FIG. 63C shows a side view of the applicator with nosepiece and thetarget vessel in a third position.

FIG. 63D shows a side view of the applicator with nosepiece penetratingthe target vessel in a fourth position.

FIG. 63E shows a side view of the applicator with nosepiece being placedin a perpendicular position.

FIG. 63F shows a side view of the applicator getting caught in thetarget vessel.

FIG. 63G shows a side view of the applicator getting caught in thetarget vessel and the back surface of the target vessel being attachedto the graft vessel.

FIG. 63H shows a side view of the nosepiece with shield.

FIG. 63I shows an isometric view of the shield.

FIG. 63J shows a side view of the operation of the shield on theapplicator in target vessel.

FIG. 63K shows a side view of the operation of the shield on theapplicator when the applicator is placed in a perpendicular position.

FIG. 64A shows a side view of the applicator with a shoe device and thegraft vessel in a first position.

FIG. 64B shows a side view of the applicator with a shoe device and thegraft vessel in a second position.

FIG. 64C shows a side view of the applicator and a shoe deviceinteracting with the target vessel in a third position.

FIG. 64D shows a side view of the applicator and the shoe device placedinside the target vessel in a fourth position.

FIG. 65A shows a side view of a graft with a suture.

FIG. 65B shows a side view of a graft with a clip.

FIG. 65C shows a top view of the graft.

FIG. 66A shows a side view of a guide wire and guide tube.

FIG. 66B shows a side view of a guide wire and applicator.

FIG. 66C shows a side view of the cutting edge.

FIG. 66D shows a side view of the cutting edge on a nosepiece.

FIG. 66E shows a side view of a cutting edge and guide rod.

FIG. 66F shows a side view of the guide wire and guide rod inside thegraft vessel in a first position.

FIG. 66G shows a side view of the second guide wire inside the targetvessel.

FIG. 66H shows a side view of the applicator using the guide wire andflexible tube in a second position;

FIG. 67A shows a side view of the applicator and wire insertion shoedevice.

FIG. 67B shows an isometric view of the wire insertion shoe device.

FIG. 67C shows an isometric view of the wire insertion shoe device withlocking mechanism.

FIG. 67D shows a side view of the applicator and wire insertion shoedevice.

FIG. 67E shows a side view of a guide rod, applicator and second guidewire in a first position.

FIG. 67F shows a side view of the applicator entering the target vesselusing a guide wire in a second position.

FIG. 67G shows a side view of the applicator and wire insertion shoedevice inside the target vessel in a third position.

FIG. 67H shows a side view of the wire insertion shoe device and thesecond guide wire inside the target vessel in a fourth position.

FIG. 67I shows a side view of the applicator inside the target vesseland graft vessel in a fifth position.

FIG. 68A shows a top view of the external anastomotic ring.

FIG. 68B, shows an isometric view of the external anastomotic ring to beattached around the anastomosis.

FIG. 68C, shows an isometric view of the external anastomotic ring in alocked position.

FIG. 68D, shows an isometric view of the partially open externalanastomotic ring.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The invention will now be described in detail with reference to theaccompanying drawings. The detailed description describes the device inrelation to a distal anastomosis during CABG surgery for joining thedistal end of the bypass graft to the wall of a natural blood vessel.This example is given by way of illustration only and is not meant tolimit the invention. Persons skilled in the art will recognize that thedevices, system and methods of the present invention are readilyadaptable for various types of anastomoses.

For the purpose of this description, the distal end of the applicatorrefers to the end that is designed for positioning at the location ofthe anastomosis site and the proximal end of the applicator refers tothe end of the applicator designed for positioning away from thelocation of the anastomosis site. Similarly, the distal end of theexpander refers to the end designed for positioning at the location ofthe anastomosis site and the proximal end of the expander refers to theend of the expander designed for positioning away from the location ofthe anastomosis site.

There are two general classes of anastomosis devices in accordance withthe present invention. One class of anastomosis devices is the class ofdirectly actuated device which is typically characterized by a shortconnection between the handle portion of the device and the front-endportion of the device. The front-end portion of the device is locateddistal to the handle portion of the device. The other class ofanastomosis devices is the class of remotely actuated anastomosisdevices that is typically characterized by a long, preferably flexibleconnection between the handle portion and the front-end portion of thedevice to allow remote actuation of the front-end portion using thehandle portion.

Both classes of anastomosis devices are designed for use with a varietyof different types of connectors. One type of connector is a deformableconnector, such as those shown, for example, in U.S. Pat. No. 6,485,496,as well as U.S. patent application Ser. No. 09/708,617, andInternational Published Patent Application No. WO 02/38055, thedisclosures of which are hereby incorporated by reference. Another typeof connector with which the anastomosis devices of the present inventioncan be used is a hyperelastic or shape memory alloy connector such as ismentioned in U.S. Pat. No. 6,485,496, the disclosure of which is herebyincorporated by reference.

Combinations of deformable and hyperelastic or shape memory alloyconnectors can also be employed. A fourth type of connector with whichthe anastomosis devices of the present invention can be used is a seriesof loose, separate staples, clips or the like which omit a connectingring such as is present in the deformable connector mentioned above.Examples of the fourth type of connector can be found in U.S. Pat. No.6,485,496 at col. 8, line 65 to col. 9, line 7, which is herebyincorporated by reference. A fifth type of connector includes staplesconnected to a bioabsorbable ring that is absorbed once the anastomosisis deployed. See U.S. Patent Publication No. 2003/0045902, which ishereby incorporated by reference. Additional embodiments of connectorsfor use with the anastomosis devices of the present invention are alsodescribed herein.

FIG. 1 shows a perspective view of a directly actuated anastomosisdevice 900 in accordance with the present invention that includes ahandle portion 920 and a front-end portion 960. Connection 902 ispreferably formed by a rigid or semi-rigid connector which is rotatablerelative to front-end portion 960 to allow positioning of handle portion920 at different orientations relative to front-end portion 960. It ispreferable that connection 902 not articulate, but connection 902 mayarticulate. The length of connection 902 can vary and it is possible,for example, to construct connection 902 from a plurality of tubularsections 905, as shown in FIG. 1 to permit customization of the lengthof connection 902 by constructing it from different numbers or lengthsof tubular sections 905, as needed.

A remotely actuated anastomosis device 901 is shown in FIG. 2. Theremotely actuated device 901 is typically characterized by handleportion 920 being connected to front-end portion 960 by a long, flexibleconnector 903, instead of by a short, rigid or semi-rigid connection 902as in the directly actuated embodiment of FIG. 1. Flexible connector 903has the advantage that due to its length and flexibility, front-endportion 960 can be operated remotely using the handle portion 920 tothereby permit an anastomosis to be done in difficult to reachlocations, or via thoracoscopic or laparoscopic surgical methods, forexample. Flexible connector 903 is also preferably connected to eitheror both of handle portion 920 and front-end portion 960 via anarticulating connection to maximize the degrees of freedom of movementof the device 901 for positioning device 901 for an anastomosis and forhanding off the device 901 from one person to another during ananastomosis procedure. Flexible connector 903 is preferably a minimallycompressible sheath containing a cable, as shown in FIG. 2, which isreleasably attached to one or both of handle portion 920 or front-endportion 960 to allow disassembly of device 901, as desired. Flexibleconnector 903 can be a ball-and-socket type shaft as described in U.S.patent application Ser. No. 09/492,558, filed on Jan. 27, 2000, or ofthe type described in U.S. patent application Ser. No. 10/736,199, filedon Dec. 15, 2003 (Attorney Docket No. ETH 5099), the disclosures ofwhich are hereby incorporated by reference.

Both the directly actuated device 900 and the remotely actuated device901 include a front-end portion or applicator 960 that is capable of atleast two distinct movements to accomplish an anastomosis. First,applicator 960 radially expands to cause radial expansion of theconnector, and subsequently, the applicator 960 executes a secondmovement to compress and/or close the connector on the graft and targetvessel. In preferred embodiments, applicator 960 returns to its startingposition by uncompressing and unexpanding as third and fourth movementsin the series of movements, to facilitate removal of applicator 960 fromthe anastomosis site.

A significant advantage of using the two separate motions to manipulatethe connector is that it helps to ensure that the connector uniformlygrasps all edges of the graft and target vessels. The first step ofexpansion serves to uniformly stretch the tissue and automaticallycenters a properly sized connector within the incisions or holes in boththe graft and target vessels. The second step of compression and/orclosure also automatically centers the tissue within the staples, clipsor other grasping elements of the connector as a result of the action ofthe anvils of the applicator 960.

When a deformable connector is employed, a variety of differentactuators can be employed to actuate the applicators and thereby deformthe connector. Exemplary types of actuators for use with connectors madeof a plastically deformable material like stainless steel, includedual-cam devices, dual-spring devices, single-cam, single-springcombination devices, and shape-memory-alloy devices.

Preferred types of actuators for use with resiliently deformableconnectors, made of a hyperelastically deformable material like Nitinol,such as that described at col. 9, lines 14-21 of U.S. Pat. No.6,485,496, include retaining or constraining devices. When a resilient,hyperelastic connector, is employed, it is preferable to constrain theannular or tubular body connecting the staple like members, separatelyfrom the staple or clip members. Once the connector is permitted todeform in the first step, by removing the constraint on the annular ortubular body of the connector, the staples or clips are subsequentlyreleased to complete the connection. In actuators for use withconnectors made of a suitable shape memory alloy, the shape memory alloyconnector can be heated to a specific temperature, e.g. warmed to bodytemperature, to cause the shape memory alloy to take a second shape toprovide the needed motion to deform the connector, without the need ofadditional, external forces. In the case of a combination of aplastically deformable material and a resilient, hyperelastic material,the connector can be a combination of a nitinol body with staples orclips which are plastically deformable. To deploy this connector, theconstraint on the body is removed to permit radial expansion and thenaxial motion of the applicator is applied to deform the staples. Such aconnector creates an anastomosis that is compliant to pressure changesdue to the resilience of the connector, thereby allowing it to pulsatemore or less, like arterial vessels pulsate during their operation.

In an alternative combination of plastically deformable and resilient,hyperelastic materials, a balloon may be employed to expand theplastically deformable body of the connector. Subsequently, a constraintis removed to permit the resilient, hyperelastic staples or clips taketheir original shape and form the connection by clamping together thevessel walls.

The connectors in the various embodiments of the present invention cantake several forms. The connector can include a ring with a plurality ofstaples, clips or the like attached thereto and be generally circular orcan be generally oval. Polygonal shapes approaching a circle or oval aremeant to be included in this description. Alternatively, the connectorneed not include a ring, in which case a plurality of loose or separatestaples, clips or the like collectively form the connector. Connectorsof this type are described, for example, at col. 8, line 65 to col. 9,line 7 of U.S. Pat. No. 6,485,496.

In the case of performing an oval anastomosis, a variety of differentapplicators can be employed. For example, a connector that is circularin its unexpanded state can be delivered by a circular applicator andactivated by an oval expander. A connector that is oval in itsunexpanded state can be delivered by an oval applicator. Alternatively,a circular applicator with an angled stapling plane and connector suchas that described in FIGS. 14-15 of U.S. patent application Ser. No.09/708,617 can be employed with a circular or oval expander.

A preferred feature of the various devices of the present invention isthe keying of the fingers of the inner and outer tubes of the applicatorto maintain alignment of the anvils at all times during the anastomosisprocedure. This feature provides a more reliable, repeatable deploymentof the connector. There are several variations on this feature which aredescribed in detail herein. For example, in one embodiment, only thefingers of the inner tube of the applicator are keyed. Alternatively,only the fingers of the outer tube of the applicator are keyed. Finally,both the fingers of the inner tube and the fingers of the outer tube maybe keyed to ensure alignment during the anastomosis procedure.Additionally or alternatively, the staple-like elements of connector 200may be keyed to the fingers of the inner tube. Keying of the fingers ofthe inner and outer tubes to one another is particularly useful whenactuating a circular applicator with an oval expander, for example.

The anastomosis devices of the present invention may be actuated by anyof a variety of different energy sources including mechanical,hydraulic, electrical, pneumatic or other conventional or similar energysources.

The anastomosis devices of the present invention are particularlysuitable for internal side-to-side anastomosis procedures, though thedevices can be used with a variety of other procedures as well, such asend-to-side anastomoses. The internal side-to-side anastomosisprocedures can be performed using semi-axial introduction orperpendicular introduction and certain device modifications may bedesirable depending upon the type of introduction that will be employed.The type of introduction may be selected based on factors such as thelocation of the anastomosis and the ease with which the anastomosis sitecan be reached for a particular introduction method. These two differentinsertion methods can also be performed using a guide wire insertiontechnique wherein the anastomosis device may be guided to theanastomosis site by a guide wire.

Referring now to the drawings, where like elements are referred to bylike reference numerals throughout the several views, various specificembodiments of the anastomosis devices and methods are described belowfor the purpose of illustrating the invention.

FIGS. 3-5 depict one embodiment of a deformable connector 200 inaccordance with the present invention. Connector 200 includes aplurality of joining elements in the form of staple elements 202 spacedaround the circumference of connector 200. A preferred connector 200 haseight staple elements 202, though connector 200 may have more or lessstaple elements 202, depending upon the size of the anastomosis.Connector 200 is preferably formed from a single piece of biocompatiblematerial such as stainless steel or titanium. Alternatively,bioabsorbable materials like polyglactin (Vicryl®) or polydioaxanone(PDS®) may be used, or a combination of a bioabsorbable material andnonabsorbable material, for example a bioabsorbable ring, holdingstainless steel staples or clips. Additionally, connector 200 may becoated with substances comprising pharmaceuticals, such as agents thatprevent or inhibit restenosis, enhance endothelial cell coverage, and/ordecrease thrombus formation.

Connector 200, as shown in FIGS. 3-5, is formed from a continuouselongate element having a sinusoidal pattern, which pattern ispreferably formed about a central ring 204 of connector 200. Thesinusoidal pattern may be customized into a sinusoidal ring 205 made upof portions 206, 208. Staple elements 202 can be formed at each portion208 of sinusoidal ring 205. The sinusoidal ring 205 of connector 200provides the radial expandability of the connector 200 since theportions 206, 208 are capable of at least partial straightening,relative to the degree of curvature of the portions 206, 208 in theinsertion position, to thereby lengthen the portions 206, 208 relativeto the central ring 204 and permit radial expansion of connector 200.While ring 205 is described as sinusoidal, one skilled in the art willrecognize that ring 205 can take any form so long as it is capable ofbeing expanded from a first diameter to a second diameter. Connector 200is fabricated for plastic deformation and thus will retain its finalshape after expansion and will not revert to its initial shape.

Each staple element 202 is preferably formed from two staple portions210, 212 which extend from a point of attachment of staple portions 210,212 to connector 200 in substantially opposite directions, as shown inFIGS. 3-5. The length, thickness and inclination of staple portions 210,212 can be varied to provide customized bending characteristics orthicknesses for staple portions 210, 212, if desired. Also, stapleportions 210, 212 may form more complex shapes, for example a “Y-shape”,so that each staple portion provides multiple extension that each engagethe tissue. In a preferred embodiment, staple portions 210, 212 extendfrom opposite sides of portions 208.

As shown in FIGS. 3-5, connector 200 is in the insertion position, theposition in which it is delivered to the anastomosis site. Preferably,the staple portions 210, 212 of this embodiment are slightly tapered ontheir outer side towards their distal free ends in one or both of radialthickness and circumferential width. That is, the diameter of a circledrawn connecting the outer surfaces of base 210 a, 212 a of stapleportions 210, 212 is greater than the diameter of a circle drawnconnecting the outer surfaces of tips 210 b, 212 b of staple portions210, 212. The outer sides 211, 213 of staple portions 210, 212 areinclined relative to a radial plane through the center of stapleportions 210, 212 such that the width W₁ of staple element 202 issmaller on the radially inner side than the width W₂ of staple element202 on the radially outer side.

Preferably, the distal tips of staple portions 210, 212 may be formedinto a curve (not shown) which anticipates the curvature of the distaltips of staple portions 210, 212 when connector 200 is formed into theconnection position. This may increase the consistency andpredictability with which staple portions 210, 212 deform during theanastomosis procedure. Portions 206 of the sinusoidal pattern may alsobe slightly tapered to a lesser thickness in the axial direction (notshown) to correspond to the taper of the adjacent staple portions 210,212, if desired.

Deformable connectors, such as that depicted in FIGS. 3-5, can bedelivered to the anastomosis site by a variety of different deliverydevices, including both directly actuated and remotely actuated deliverydevices. The various delivery devices will include an applicator and anexpander for expanding the applicator. Several embodiments ofapplicators and expanders suitable for delivery of deformable connectorsare described below.

FIG. 6 is a perspective view of an applicator 100 for use in ananastomosis system in accordance with the present invention, shown inthe insertion position. Applicator 100 includes an inner tube 102, anouter tube 104 and a distal attachment such as a shoe 106. As shown inFIG. 6, applicator 100 is in the insertion position in which theapplicator 100 is delivered to the anastomosis site. In use, adeformable connector 200, such as that described in FIGS. 3-5, isassociated with the applicator 100 for delivery to the anastomosis sitewith the applicator 100. The inner tube 102 is designed to accommodatean expansion device 300 (described below), which, when actuated, causesexpansion of the applicator 100 from the insertion position shown inFIG. 6 to the expanded position shown in FIG. 7.

As shown generally in FIGS. 6-7 and 14-17, and more particularly in FIG.15, to permit expansion of the connector 200, when positioned on theinner tube 102, inner tube 102 has a plurality of slits 116 extendingfrom the distal end of inner tube 102 in a proximal direction (towardthe proximal end of inner tube 102) for a sufficient distance to permitthe desired degree of expandability of inner tube 102 by expansiondevice 300. Specifically, the length of the slits 116 is sufficient topermit sufficient radial deflection of the fingers 118 of the inner tube102 located between each of the slits 116 to provide the desired degreeof expansion of the inner tube 102 and thus the desired degree ofexpansion of the connector 200. For example, the length of the slits 116may be from 2-10 times the diameter of the inner tube 102, but mostpreferably approximately five times the diameter of the inner tube 102.

As is shown in FIG. 16, at least a portion of the lumen 120 of the innertube 102 is preferably tapered from a greater diameter at the distal endof the inner tube 102 to a lesser diameter in the direction of theproximal end of the inner tube 102. Tapered surfaces 122 of fingers 118of inner tube 102 are detailed in FIG. 15. The angle of the taperrelative to the distal end of inner tube 102 is preferably from about30° to about 45°. The tapered surfaces 122 are adapted to interact withcorresponding surfaces 304 of expansion head 302 of expansion device 300(described below) in a manner whereby retraction of the expansion device300 in the proximal direction, relative to inner tube 102, urges fingers118 of inner tube 102 radially outward to cause expansion of inner tube102 and thus connector 200.

Inner tube 102 is also provided with a plurality of anvils 112 each ofwhich is located on the distal end of one of fingers 118 of inner tube102. Anvils 112 may serve three different functions in the operation ofapplicator 100. First, anvils 112 are provided with tapered surfaces 122as described above to cause expansion of fingers 118 of inner tube 102when corresponding surfaces 304 of expansion head 302 are drawnproximally relative to inner tube 102. Second, anvils 112 include aseries of angled surfaces 126 on the sides of anvils 112 that aredesigned to mate with the corresponding angled surfaces 306 of expansionhead 302 to ensure that when fingers 118 of inner tube 102 move radiallyoutward that the spacing between fingers 118 remains substantiallyuniform to thereby provide substantially uniform expansion of inner tube102. A third function of anvils 112 is to provide surfaces 114 thatinteract with corresponding surfaces 110 of anvils 108 of the outer tube104. Surfaces 110, 114 may optionally be curved. Each pair of anvils108, 112 is designed to interact with staple elements 202 of connector200 shown in FIG. 3 to bend the staple elements 202 of connector 200into the position that creates the anastomosis. Preferably, theapplicator 100 includes eight anvils 108, eight anvils 112 and eightstaple elements 202 of the connector 200. The number of anvils andstaple elements may vary depending on the size of the anastomosis. Forexample, for smaller vessels, connector 200 may have seven or lessstaple elements 202, or for larger vessels, connector 200 may have nineor more staple elements 202. In each case, applicator 100 preferablywould include a number of anvils 108, 112 that correspond to the numberof staple elements 202.

The outer tube 104, as shown generally in FIGS. 6-7 and 9-13, and moreparticularly in FIG. 9, also has a plurality of slits 130 that form aplurality of fingers 132. Upon expansion of inner tube 102, outer tube104 also expands by virtue of slits 130 in outer tube 104 as shown inFIG. 7.

In one embodiment, outer tube 104 is capable of movement in an axialdirection relative to inner tube 102 to permit the distal ends of innerand outer tubes 102, 104 to move together in the second step of theperformance of an anastomosis: to compress and/or close the connector onthe graft and target vessel. The movement of the distal ends of innerand outer tubes 102, 104 together bends staple elements 202 of connector200 from an insertion position to a connection position whereby theanastomosis is formed. To obtain optimal, blood tight sealing of thegenerally elastic vessel walls, the staple elements 202 are oftenrequired to deform to a shape having a diameter less than the combinedthickness of these walls. This requires the anvils to come closer toeach other than this combined thickness, resulting in tissuecompression, which can lead to some damage. It is advantageous to keepthis compressed area as small as possible to limit any potential damage,by reducing the front area of at least one of the paired anvils 108, 112facing each other. As shown in FIG. 6, anvils 108 therefore have theirtips rounded in the axial direction.

Referring to FIGS. 6 and 9, to better hold connector 200 in position onapplicator 100 during insertion and expansion, anvils 112 of inner tube102 may include slots 128 sized to accept a portion of staple elements202 of connector 200. Corresponding slots 138 sized to accept a portionof staple elements 202, may also be found in anvils 108 of outer tube104. In a preferred embodiment, one set of tips 210 b or tips 212 b isdisposed within slots 128 of inner tube 102 and the other set of tips210 b or tips 212 b is disposed within slots 138 of outer tube 104. Asshown in FIG. 18 b, slots 128, 138 may be shallower than shown in FIG. 6or 13, and may have a more scalloped appearance so as not to require thenotching of material from anvils 108, 112 across their entire thickness.Surfaces 110 of inner tube 102 and surfaces 114 of outer tube 104 formthe inner boundary of slots 128, 138, respectively.

Slots 128, 138 hold connector 200 in position during insertion andexpansion by virtue of the application of slight, static pressure to theends of staple elements 202 by the inner and outer tubes 102, 104, thussecurely engaging connector 200, especially when the tips 210 b, 212 bof staple elements 202 are pre-bent to fit into curved surfaces 110,114. Alternatively, the distance between the anvil faces is defined assufficiently less than the length of the preformed staple legs, suchthat when one end of connector 200 is disposed at the extreme depth ofone of curved surfaces 110, 114, the other end of connector 200 wouldextend beyond the opposing anvil face, i.e. rests partially in the otherone of curved surfaces 110, 114. In either case, the penetrating tips210 b, 212 b of staple elements 202 are substantially shielded withinslots 128, 138, until the staple elements 202 are deformed to theirfinal joining position. In this way, tips 210 b, 212 b are preventedfrom prematurely engaging any tissue during the manipulation ofapplicator 100 required to insert the distal end of applicator 100 intothe graft and target vessels. This type of configuration can also holdseparate staple elements 202 formed of staple portions 210, 212, whenthese are not connected by the sinusoidal ring formed by portions 206,208. The pressure on the tips 210 b, 212 b of staple elements 202 can beincreased by moving outer tube 104 axially in the distal directionrelative to inner tube 102 to deform the staple-like elements to theirjoining position. The compression step preferably occurs after the stepof expanding connector 200.

Following the compression step, to remove applicator 100 and leaveconnector 200 in position, outer tube 104 is moved axially in a proximaldirection relative to inner tube 102 to release the pressure onconnector 200, and thereby permit connector 200 to disengage from slots128, 138 of inner and outer tubes 102, 104.

In a more preferred embodiment of the invention, outer tube 104 ismaintained in a fixed position throughout the anastomosis procedure. Inthis embodiment, inner tube 102 is moved in an axial direction towardsthe distal end of outer tube 104 during the anastomosis procedure tocause deformation of staple elements 202 of connector 200. Once theanastomosis is created, inner tube 102 can return to its originalposition by movement in an axial direction away from the distal end ofouter tube 104. This embodiment is preferred since it reduces the numberof moving parts required to effect the required motion. Alternatively,the invention also contemplates moving both inner tube 102 and outertube 104 relative to one another.

Referring to FIGS. 12 and 15, to maintain alignment between inner andouter tubes 102, 104 during use of applicator 100, inner tube 102 has akey 127 in the proximal end thereof that mates with a key 137 formed inouter tube 104. Keys 127, 137 help to maintain axial alignment betweencurved surfaces 110, 114 of the inner and outer tubes 102, 104 andensure uniform expansion of applicator 100 and connector 200 as outerand inner tubes 102, 104 expand under the force of expander 300.

An alternate keying mechanism is depicted in FIGS. 18A and 18B. FIG. 18Adepicts three adjacent fingers 132 of outer tube 104 that have a specialpattern for slits 130 in outer tube 104 which can be used to create akeying mechanism for keying fingers 132 of outer tube 104 with fingers118 of inner tube 102. The special pattern of slits 130 shown in FIG.18A provides small protrusions 131 that can be bent to extend inwardlyfrom fingers 132 of outer tube 104 as shown in FIG. 18B to a positionthat locks around fingers 118 of inner tube 102. As with the embodimentdescribed in connection with FIGS. 12 and 15, such a mechanism maintainsalignment of fingers 132 of outer tube 104 with fingers 118 of innertube 102 during use of applicator 100. In this embodiment, the positionof protrusions 131 alternates with each finger 132 as shown in FIG. 18B.

One advantage of the provision of a keying mechanism that maintainsalignment between the fingers 118, 132 of the inner and outer tubes 102,104 is that keyed expander head 302, described below, can be greatlysimplified as it is no longer needed to assist with ensuring thisalignment. It is still required, as one function of expander head 302 isto ensure substantially uniform expansion of the inner and outer tubes102, 104. The keying mechanism substitutes in part for keyed expanderhead 302 by performing this function of maintaining alignment betweenthe fingers 118, 132 of the inner and outer tubes 102, 104 and in turnthe curved surfaces 110, 114 of the inner and outer tubes 102, 104.

Another keying mechanism is depicted in FIGS. 18C-18D. In FIG. 18C, eachfinger 118 of inner tube 102 includes a longitudinal groove 119 therein.Each finger 132 of outer tube 104 is provided with longitudinal slots121 to create an area 123 located between longitudinal slots 121 thatcan be deformed downwardly to the position shown in FIG. 18D. Outer tube104 may include a single pair of longitudinal slots 121, or, morepreferably, each finger 132 of outer tube 104 may have one or morelongitudinal slots 121 spaced from one another in an axial orlongitudinal direction. To key each finger 132 of outer tube 104 to eachfinger 118 of inner tube 102, areas 123 of finger 132 of outer tube 104are deformed downwardly in the direction of inner tube 102, as shown,for example, in FIG. 18D such that area 123 is at least partiallydisposed within longitudinal groove 119 of finger 118 of inner tube 102.Preferably, each longitudinal groove 119 is substantially centered infinger 118 of inner tube 102. Alternatively, outer tube 104 can be madefrom a special type of tube, having longitudinal protrusions on itsinner surface, regularly spaced inside its inner circumference. Such aspecial tube can for example be made by the process of extrusion, whichis commonly used for the production of all kinds of tubes. If properlydimensioned, this results in an outer tube 104, having fingers 132, eachhaving one or more longitudinal protrusions extending inwardly, whichcan key with one or more appropriately placed grooves on the outside ofinner fingers 118. These matching grooves on inner fingers 118 of innertube 102 can be obtained by making tube 102 also from an extrudedprofile, having a grooved outer shape matching the inner shape of outertube 104. Additionally or alternatively, connector 200 can be keyed toinner fingers 118. This can for example be done by providinglongitudinal grooves 119 in inner fingers 118 and pre-bendingstaple-like elements 202 of connector 200 slightly towards the centralaxis of connector 200 to a diameter less than the diameter of the ring205. Connector 200 is positioned on inner fingers 118 such, thatstaple-like elements 202 are at least partially disposed withinlongitudinal grooves 119, while the extreme tips are pre-bent outwardsmore markedly so these tips still fit in curved surfaces 110, 114 ofanvils 108, 112. Alternatively, connector 200 can be manufactured froman extruded tube having longitudinal protrusions on its inner surface asdescribed above, so that each staple-like element 202 has longitudinalprotrusions extending inwardly, fitting in grooves 119 of inner fingers118.

Again, use of the keying mechanism of FIGS. 18C-18D permits operation ofthe device without the need for keyed expander head 302. Instead, asimple, smooth cone can be used to expand inner and outer tubes 102,104, since the keying mechanism maintains proper alignment of inner andouter tubes 102, 104 during operation of applicator 100.

During successful deployment of connector 200, connector 200 undergoestwo distinct motions: radial expansion of ring 205, and axialcompression of staple elements 208, 210. The required sequential motionscan be achieved with dual-cam, single-cam/single-spring, or dual-springdrive mechanisms, or, in the alternative, by using shape memory orhyperelastic alloys. In addition, those skilled in the art can use theteachings provided herein to devise other types of drive mechanisms toachieve the same output motion.

Referring now to FIGS. 19-26, there is shown one embodiment of anexpander 300 in accordance with the present invention. Expander 300 isformed from a combination of an expander head 302 and an expander rod ortube 312. Expander head 302 is preferably made from a hard materialcapable of expanding inner and outer tubes 102, 104 under the loadrequired to expand connector 200. Expander rod or tube 312 may be asolid rod or a hollow tube (as shown in FIG. 20) and may be provided atthe distal end of expander rod or tube 312 with an angled flare, asshown in FIG. 25, or a flange 314, as shown in FIG. 20. The proximal endof expander rod or tube 312 can be attached to an actuation device, forexample, by an external threaded connection 316 as shown in FIG. 19, orby an internal thread and a threaded screw 338 as shown in FIG. 26. Anyother type of connection known to those skilled in the art may be usedto connect the proximal end of rod or tube 312 and the actuation device.

Preferably, expander rod or tube 312 is insert-molded to expander head302 to provide a reliable connection between expander rod or tube 312and expander head 302 and prevent expander head 302 from disengagingfrom expander rod or tube 312 during use of applicator 100. For thispurpose, flange 314 provides structure for mating with a correspondingstructure of expander head 302 to provide a mechanical bond betweenexpander rod or tube 312 and expander head 302. In a preferredembodiment, the surface of flange 314 is defined to maximize the bondingforce.

In the embodiment shown in FIGS. 19-22, expander 300 includes anexpander head 302 that has an opening 302 a that communicates with apassageway 318 located in the distal end of expander tube 312 (FIG. 20).Passageway 318 and opening 302 a together allow materials, such asdrugs, genes or cells, or devices, such as fiber optic bundles or guidewires to be passed through the expander tube 312 for the purpose ofeither guiding applicator 100 to and/or from the anastomosis site, orintroducing, for example, drugs designed to reduce or prevent scartissue formation at the anastomosis site. Pharmaceuticals for preventingor inhibiting restenosis or to enhance endothelial cell coverage couldbe delivered through passageway 312. Exemplary drugs include, but arenot limited to, anti-platelet agents, anti-coagulants, calcium-channelantagonists, ACE inhibitors, nitric oxide, anti-inflammatory agents,growth factor inhibitors, antioxidants and antibiotics. Thepharmaceuticals could be delivered in solution or as a viscous gel.Other treatments such as autologous endothelial or stem cells, with orwithout genetic modification, and genetic vectors could be delivered inthis manner as well. Preferably, passageway 318 is a bore that runs thelength of tube 312, but passageway 318 may also communicate with aseparate lumen or lumens that run within or outside tube 312.

Referring to FIGS. 8A-8F, an alternative embodiment of applicator 100 isdepicted, wherein outer tube 104 is divided into a distal portion 1041and a proximal portion 1042 that move axially relative to each other.Distal portion 1041 has recesses 1045 and proximal portion 1042 haspushing mechanisms 1046 (which can be, e.g., rods, plates or cylinders)that are sized to be at least partially disposed within recesses 1045.This design is especially suitable for delivery of separate stapleelements, like U-shaped clips 2021, that can be disposed, as shown inFIG. 8A, within recesses 1045 at a location distal to pushing mechanisms1046.

In such an embodiment, outer tube 104 can be formed as a radiallyexpandable cartridge that expands from a first position, shown in FIG.8C, to a second position, shown in FIG. 8D. Outer tube 104 can includeouter portions 1041 b connected by web portions 1041 c. Recesses 1045are preferably located in outer portions 1041 b. In a preferredembodiment, outer tube 104 includes four outer portions 1041 b, each ofwhich house a separate clip or staple 2021 in its respective recess1045.

Referring to FIG. 8C, in the starting position, adjacent outer portions1041 b are located relatively close together, such that web portions1041 c fold to form slits 1041. Pushing mechanisms 1046 of proximalportion 1042 are positioned within recesses 1045.

After the inner tube 102 and outer tube 104 have been expanded to centerthe applicator within the holes of the target and graft vessel, outertube 104 is moved in an axial direction towards anvils 112 of inner tube102. Distal portion 1041 of outer tube 104 retains both clips 2021 andpushing mechanisms 1046 such that as outer tube 104 is moved in axialdirection, the target and graft tissue is compressed between anvils 112and distal portion 1041. Once the tissue has been compressed, distalportion 1041 can no longer move, and pushing mechanisms 1046 push clips2021 out of distal portion 1041 until clips 2021 penetrate the tissueand are subsequently deformed to a joining position by distal anvils112. As with prior embodiments, anvils 112 may be shaped to suit thespecific type of staple or clip 2021.

Alternatively, distal portion 1041 may extend concentrically aboutportion 1042. This design allows distal portion 1041 to be movedindependently, so that it can be used to first clamp the tissue againstthe distal anvils 112. This offers the additional advantage of allowingvisual inspection of the position of the tissue, before actuallydeploying the staples or clips 2021. FIGS. 8D and 8E show top and sidecross-sectional views of clips 2021 in a preferred joining positionspaced at four positions about the anastomosis holding the vessel walls.

In still another embodiment (not shown), pushing mechanism 1046 may behollow rods, similar to needles that are disposed within recesses 1045and are long enough to axially traverse recesses 1045 and penetrate thetissue. The lumen of the needles may be connected to a centralreservoir, which can be pressurized. The lumen of the needles maycontain any joining means to connect tissue, such as self-expandingNitinol staples, or, more preferably, biocompatible glue. Pressurizingthe lumen of the needles may push out the joining means. In case ofglue, the device could work as follows: applicator 100 is expandedinside the holes in the walls of the vessels to be joined. Distal andproximal portions 1041 and 1042 are pushed distally towards anvils 112,so that both walls are clamped and substantially penetrated by theneedles. Subsequently, distal portion 1041 is maintained stationaryrelative to the anastomosis site to keep the tissue clamped, andproximal portion 1042 is pulled proximally, to retract the needles outof the tissue while pressurizing the lumen of the needles to push glueout of the end of each needle. In this way, glue fills the hole made byeach needle as the needles are withdrawn from the tissue, therebyforming plugs of glue inside the tissue, joining the tissue. Additionalglue may be applied from outside the anastomosis, and an externalprotective ring 1100 may be used, if desired. The internal clamping ofthe tissue with applicator 100 can be released when the glue hashardened to a sufficient strength.

It is also possible to connect the tissue with glue applied from theoutside only. In this case, applicator 100 resembles the embodimentshown in FIGS. 6 and 7, however, it does not need to carry connector200, and therefore does not require recesses 114 and 138. Applicator 100is instead used to clamp the vessel walls together from the inside,preferably by first expanding applicator 100, and subsequently clampingthe tissue together by axially moving outer tube 104 towards anvils 112of inner tube 102, but other sequences may be used as well, depending onthe situation. Glue can then be applied externally, on the externalsurface of the anastomotic line.

Biocompatible glue may be used in combination with any type of connector200, to reinforce or seal the mechanical bond, provided by the deformedstaple like elements of connector 200. Glue is preferably applied fromthe outside of the anastomosis. This can be done before making thearteriotomies in both vessels to be joined, thus first gluing togethertwo vessel walls, and subsequently making an arteriotomy through bothwalls and deploying applicator 100 and connector 200, therebymechanically reinforcing the glued tissue bond. Glue can also be appliedduring the construction of the anastomosis, for example by providingglue on the outside of the adjoining vessel walls after expansion ofconnector 200, before or after closure of staple-like elements 202.Finally, glue can be applied on the outside of the adjoining vesselwalls after completion of the anastomosis and removal of applicator 100.

It is thus understood, that throughout this specification, andespecially where deployment methods are described in detail, referenceto joining the tissue with connector 200 is explicitly meant to includeuse of separate staples, or a unitary connector, or glue, or any othersuitable or conventional means.

To facilitate the insertion of applicator 100 into the holes in thewalls of the vessels to be joined, and in particular the insertion ofthe distal anvils 112 into the target vessel, using one of the insertionmethods described later in this document, expander head 302 can beequipped with a nose cone. The nose cone can have a more or lessconical, streamlined shape in an axial direction relative to the centralaxis of the applicator, for example as shown previously in FIG. 20 ofU.S. patent application Ser. No. 09/708,617, or it can have a more orless conical, streamlined protrusion extending in a radial directionrelative to the central axis of the applicator, thus taking the shape ofan insertion shoe 106, as shown in, for example, FIGS. 6, 22, 23, 27,and 28A, or any angle in between.

Shoe 106 must be retrievable through the deployed, expanded ring 205 ofconnector 200, to allow removal of applicator 100 after completion ofthe anastomosis. If the contour of shoe 106, in a plane perpendicular tothe central axis of the applicator, has a greatest length less than thediameter of the expanded connector 200, the shoe can be attached toexpander head 302 in a fixed, non-moving way. If the length of shoe 106exceeds the diameter of expanded connector ring 205, shoe 106 must beable to decrease its dimensions in this plane by being retractable,pivotable, movable, deformable, deflatable or any combination of these,or must be able to decrease its dimensions in this plane by some othermeans known to those skilled in the art. Alternatively, shoe 106 can bedetachable, initially held by mechanical means or magnetic force, andretrieved separately from the applicator, thus offering additionaldegrees of freedom for optimal manipulation, for example by extractionthrough an alternative route like the native, target vessel.

The nose-cone must also fit within the lumen of the vessels to bejoined, in particular the target vessel, which is generally the smallervessel, before and after the device is brought into a delivery position,substantially perpendicular to the target vessel, as described later on.Therefore, if the contour of the nose-cone has a greatest length in aplane parallel to the central axis of the applicator, that exceeds thediameter of the target vessel, the nose cone has to be able to decreaseits dimensions in this plane by being retractable, pivotable, movable,deformable, deflatable or a combination of these, or must be able todecrease its dimensions in this plane by some other means known to thoseskilled in the art. Alternatively, it can be detachable as describedabove.

In a preferred embodiment, shown in FIGS. 6 and 22, shoe 106 is madefrom a relatively soft, flexible material that allows toe 107 of shoe106 to bend easily in use from the position shown in FIG. 7, whereinshoe 106 has a length and area that is longer and greater than the innerdiameter or area of expanded connector 200, to the position shown inFIG. 26B wherein shoe 106 deforms to fit into an area within innerdiameter of expanded connector 200, thereby permitting shoe 106 to beremoved through the interior of expanded connector 200 during the finalstep of the anastomosis procedure. To facilitate bending of toe 107, toe107 may be connected to shoe 106 by a narrow constriction 109 to providea weak point in shoe 106 at which bending of toe 107 can occur.

Shoe 106 can be over-molded onto expander head 302 to ensure a good fitand thereby prevent shoe 106 from disengaging from expander head 302during use of applicator 100. Expander rod or tube 312 may be plasticand be molded simultaneously with expander head 302. Alternatively,expander head 302 may be metal fabricated by, for example, metalinjection molding or any other suitable method, in which case, it ispossible, but not necessary, to form expander head 302 integrally withexpander rod or tube 312 as a single unit. It is preferred in thisembodiment to include structure for forming a mechanical bond betweenexpander head 302 and shoe 106 for the purpose of strengthening theconnection between these elements.

In an alternative embodiment, shown in FIGS. 23, 26A and 26C, shoe 106 ais preferably fabricated from a hard material. In this embodiment, shoe106 a does not deform, but rather, provision is made for shoe 106 a totilt and move out of the way during operation and removal of the device.Specifically, shoe 106 a is attached to a spring 351, for example, viascrew 105, as best seen in FIG. 26A. Spring 351 is, in turn, attached tothreaded screw 338. This arrangement permits shoe 106 a to move upward,radially outward and tilt relative to outer tube 104 during expansion,such as the position shown in FIG. 26C, and subsequently be removedthrough expanded connector 200.

It is also possible to fabricate shoe 106 a and expander head 302 from asingle material. In this embodiment, pull tube 352 is preferably flaredas shown, for example, in FIG. 25, to increase stiffness of the conicalpart to provide support for the expansion of applicator 100, thusallowing deployment of connector 200, but the material from which tube352 is made is flexible enough to allow removal of applicator 100 fromconnector 200 after the anastomosis is complete.

In another embodiment, the material selected for fabrication of shoe 106a is such that it is capable of forming a chemical bond with thematerial of expander head 302 to further reinforce the connectionbetween shoe 106 a and expander head 302. Alternatively, a mechanicalconnection and/or an adhesive can be employed for this purpose.

In the embodiments shown in FIGS. 24-25, the shoe 106 a is formedseparately from expander head 332 of FIG. 24, and expander head 342 ofFIG. 25, and may be connected to the applicator 100 with a band or cordor thread, which may be elastic, or via a spring 351. In this way, shoe106 a can move from a first, insertion position, which is more radiallyoriented relative to the central axis of the applicator 100, to asecond, removal position, which is more parallel to the central axis, asshown in FIG. 26D, thus reducing the size of the shoe in a planeperpendicular to the applicator. The connecting band or spring 351 isattached to shoe 106 a, for example by using a screw through hole 111,and may, but does not need to, run through the entire length of hollowexpander rod 350, to be attached at its proximal end.

To allow additional stability of shoe 106 a on expander head 332 of FIG.24, and expander head 342 of FIG. 25, during insertion, shoe 106 a canbe provided with a key 113 which mates with a corresponding notch 334 or344 in expander head 332 or expander head 342. Expander head 332 of FIG.24 has two protuberances 334 for this purpose. FIG. 26B shows theunderside of shoe 106 a. Shoe 106 a includes a recess 111 for engagementwith the distal end of expander 300 and keys 113 that mate withcorresponding protuberances 334 or 344 in expander heads 332, 342,respectively. Alternatively or additionally, magnetic force can be usedto generate additional stability between shoe 106 and expander head 332.

Referring to FIGS. 27A-27F, there is shown an embodiment of theinvention which does not require an expander head. Expander 300 b isformed from a combination of expander tube 312 b and a flange 314 b atthe distal end thereof as shown in FIG. 27B. Expander rod 312 b may be ahollow tube as shown in FIG. 27D. The proximal end of expander tube 300b may include a threaded connection 338 b as shown in FIGS. 27C-27D, oralternatively the spring 351 may be laser-welded or the like, to theexpander tube 312 b. The device of this embodiment also includes a shoe106 b, shown in FIG. 27A which may be attached via a screw 105 b to aspring 351 b which may, but need not, run the length of expander tube312 b, as shown in FIG. 27D. The proximal end of spring 351 b may beattached to a threaded screw 338 b, as shown in FIG. 27D. Shoe 106 b ispreferably made from a hard material in this embodiment since the wholeof shoe 106 b moves during expansion, as discussed below.

In the embodiment of FIGS. 27A-27F, expander 300 b is pulled proximallyto cause expansion of the applicator 100 from the insertion position ofFIG. 27E to the expanded position of FIG. 27F. Flange 314 b rides onmating surfaces of inner tube 102 to cause expansion of inner tube 102which, in turn, causes expansion of outer tube 104, as can be seen inFIG. 27F. Since shoe 106 b is attached to spring 351 b, it is permittedto move from the position shown in FIG. 27E to the position shown inFIG. 27F during expansion. Referring now to FIGS. 28A-28F, there isshown an alternative embodiment of an expander 300 a in accordance withthe present invention. Expander 300 a is formed from a combination ofexpander head 302 a and expander tube 312 a. Expander tube 312 a may bea hollow tube, as shown, and is provided with a flange 314 a at thedistal end thereof. The proximal end of expander tube 312 a may includea threaded connection 316 a as shown in FIG. 28C. Preferably, expandertube 312 a is insert molded into expander head 302 a to provide areliable connection between expander tube 312 a and expander head 302 ato prevent expander head 302 a from disengaging from expander tube 312 aduring use of the applicator 100. For this purpose, flange 314 aprovides structure for mating with a corresponding structure of theexpander head 302 a to provide a mechanical bond between expander tube312 a and expander head 302 a. In a preferred embodiment, the surface offlange 314 a is defined to maximize the bonding force. In anotherpreferred embodiment, the expander head 302 a is over-molded onto tube312 a. Expander head 302 a is preferably made from a hard material whichis capable of expanding inner and outer tubes 102, 104 under the loadrequired to accomplish the expansion.

The shoe 106 a is separate from expander head 302 a and is over-moldedonto a spring wire 117 a that provides a mechanical connection betweenthe shoe 106 a and the expander tube 312 a, and also acts as a hingethat allows shoe 106 a to rotate toward a more axial position relativeto the center-line of the applicator. Shoe 106 a can be made of anybiocompatible material, hard or soft, because shoe 106 a can move to itssecond, removal position, without having to rely on deformation of theshoe 106 a.

As shown in FIGS. 28D and 28F-28G, shoe 106 a need not include a heel,and thus differs from shoe 106 of FIG. 26B. The advantage of this designis that any chance of inadvertently hooking the heel behind the expandedconnector is avoided. To re-establish the streamlined contour, expander302 a includes heel 301 a eccentrically on one side.

To provide shoe 106 a additional stability relative to expander head 302a, during insertion, shoe 106 a can be provided with protuberances 113 awhich press fit with a corresponding recesses 334 a in expander head 302a. This arrangement helps maintain shoe 106 a in position relative toexpander head 302 a during insertion of the device, but permits shoe 106a to move upwardly when anvils 112 of inner tube 102 contactprotuberances 113 a and thereby release protuberances 113 a fromrecesses 334 a during expansion of expander head 302 a. Expander head302 a of FIGS. 28F-28G has two recesses 334 a for this purpose. FIG. 28Dshows the underside of shoe 106 a. Shoe 106 includes a longitudinal key111 a for engagement with a slot 303 a in the distal end of expanderhead 302 a.

Referring now to FIGS. 29A-29C, there is shown an expander 300 b whichis suitable for carrying out an oval or elliptical anastomosis byfurther expanding the device in the axial direction of the target vesselthan in the transverse direction. In this embodiment, the expander head302 b is made in an oval shape but is employed with a round applicator,for ease of manufacture. Thus, the conical expander head 302 b has anoval ground plane which expands the applicator more in a first directionthan in a direction perpendicular to the first direction. The outer edge305 b of the asymmetric expander 300 b may be adapted to fit inside thecontour of the fingers 118 of inner tube 102. An extra degree ofover-expansion in one direction can be achieved by over-sizing the longaxis of the expander 300 b, as shown. Thus, the expander 300 b alsoforms an insertion foot, in this case with a symmetrical toe 107 b andheel 109 b as a result of the increased size in one direction, whichshould be directed along the central axis of the target vessel. Theinitial arteriotomy in the target vessel can be larger, allowing easyinsertion of the device using a method much like the perpendicularinsertion method described below.

As discussed above, applicator 100 carries out a four-step process toaccomplish an anastomosis. The first step is the expansion of inner andouter tubes 102, 104 from an initial state to an intermediate state tothereby expand connector 200. The second step is to move at least one ofinner and outer tubes 102, 104 relative to the other of inner and outertubes 102, 104 from the intermediate state to a release state to formconnector 200 into the desired shape for making the anastomosis. Thethird step is to return inner and outer tubes 102, 104 to their originalrelative positions, and the fourth step is to return inner and outertubes 102, 104 to the unexpanded final state. It is not necessary toperform all four steps sequentially, and thus, for example, the thirdand fourth steps could potentially be combined into a singlesimultaneous motion of the various moving parts to achieve theobjectives of returning inner and outer tubes 102, 104 to their originalpositions and unexpanded state.

In a preferred embodiment, one component of applicator 100 is heldstatic and other components of applicator 100 are moved relative to thestatic component. Preferably, outer tube 104 is maintained as the staticcomponent since this may simplify the mechanics of the actuation ofapplicator 100. The following embodiments of drive mechanisms oractuators in accordance with the present invention are described inrelation to actuation of an applicator that maintains outer tube 104 ina static position and moves inner tube 102 relative to outer tube 104.Of course, persons of skill in the art are capable of applying the basicconcepts of the various actuators described below to embodiments where,for example, inner tube 102 is maintained in a static position and outertube 104 is moved relative to inner tube 102, or to embodiments whereboth inner and outer tubes 102, 104 are moved relative to one another.

Drive Mechanisms

In performing the anastomosis procedure, a connector is deployed via twosystems, the activation mechanism and the drive mechanism or actuator.Energy, which may be mechanical, hydraulic, pneumatic, electrical, etc.,is input into the activation mechanism. The activation mechanism thentranslates the input energy into a motion that drives the drivemechanism. Preferably, the activation mechanism translates the inputenergy into either a pulling motion or a pulling and then a releasingmotion that drives the drive mechanism. There are four basic types ofdrive mechanisms described below, a dual-cam drive mechanism, asingle-cam/single-spring drive mechanism, a dual-spring drive mechanismand a shape memory alloy mechanism. Each system is compatible with onetype of output motion from the activation mechanism, either pull orpull-and-release. The drive mechanism or actuator utilizes this motionto manipulate the tubes and deploy the connector.

Dual-Cam Actuation

In a mechanism that utilizes dual-cam, direct actuation, the amount ofexpansion of the connector and the compression of the staple elementsare independently governed by cam tracks. Once the inner and outer tubes102, 104 have deployed the connector, the cam tracks force the inner andouter tubes 102, 104 back to their original position, allowing forpositive return of the device to its original position without the useof stored energy. This configuration generally employs a continuous pullfrom an activation mechanism. Each face of the cam may have a unique camtrack. The geometry of the cam tracks dictates the timing of, andcontrols the two distinct motions required for the anastomosis.Referring to FIG. 30A, there is shown a device 719 for controlling therelative positions of outer tube 104, inner tube 102 and expander 300relative to each other comprising a cover 703 and a lever and camactuator 700.

Referring to FIG. 30B, there is shown a lever and cam actuator 700.Lever and cam actuator 700 is connected to applicator 100. Outer tube104 is connected to rotatable connection 702. Inner tube 102 is fixedlyconnected to disk 704. Expander 300 is fixedly connected to disk 706.Rotatable connection 702 can freely rotate 360 degrees relative to leverand cam actuator 700. Disc 706 can freely rotate 360 degrees relative tolever 716. Disc 704 can freely rotate 360 degrees relative to lever 714.This allows the user to suitably position applicator 100 and lever andcam actuator 700 relative to the anastomosis site.

In this embodiment, the proximal end of expander 300 is connected todisk 706, via threaded connector 316. Disks 704, 706 are positioned asshown in FIG. 30B to engage with levers 714 and 716, respectively,whilst being permitted to rotate about the axis of applicator 100.Levers 714, 716 are adapted for lateral movement at a substantially90-degree angle relative to disks 704, 706 being pivotally mounted inpivot points 724, 718 respectively. Pivot points 724, 718 are containedin chassis 701. Respectively levers 714 and 716 include cam followers708 and 720, adapted to ride in cam tracks 710 and 722. Said cam tracksare housed in shuttle 712. Shuttle 712 is attached to a cable 726, orother actuation means. Cover 703 is fastened in place to chassis 701thereby limiting the movement of shuttle 712 to one along the lengththereof.

In operation, translation of cable 726 in a proximal direction causestranslation of shuttle 712 in a proximal direction, which causes camtracks 710 and 722 to subsequently cause the translation of camfollowers 708 and 720 as dictated by the unique configuration of the camtracks. Respectively, translation of cam followers 708 and 720 causelevers 714, 716 to pivot about pivot points 724, 718. Since levers 714,716 are pivotally mounted at pivot points 724, 718, distal movement ofthe proximal portions of levers 714, 716, as shown in FIG. 30B,translates to proximal movement of the distal portions of levers 714,716 which, in turn, translates to proximal movement of inner tube 102and expander 300. Similarly, proximal movement of the proximal portionsof levers 714, 716 translates to distal movement of inner tube 102 andexpander 300 as a result of the pivotal mounting of the levers 714, 716.

As a result, in the starting position, cam followers 708, 720 arelocated at the distal-most position within cam tracks 710, 722. As camfollowers 708, 720 are pulled proximally within cam tracks 710, 722, camfollowers 708, 720 move downwardly at different times to first causelever 716 to pull the expander proximally relative to outer tube 104,and then cause lever 714 to pull inner tube 102 proximally relative toouter tube 104. A second embodiment of a dual-cam actuation mechanism isdepicted in FIGS. 31-37. Front-end portion 960 shown in FIG. 31 includesa housing 964. Dual-cam 961 is mounted at its center point 965 forrotational movement in housing 964. Each side of cam 961 has a cam track966, 967 as shown in FIGS. 35 and 37, respectively. Cam tracks 966, 967are generally c-shaped (but are not identical) and are designed toproduce coordinated linear movements of inner tube 102 and pull tube 352that cause the expansion and compression of connector 200, and thenreturn inner tube 102 and pull tube 352 to their starting positions.Pull tube cam track 966 includes a first section 966 a, a second section966 b and a third section 966 c. Similarly, inner tube cam track 967includes a first section 967 a, a second section 967 b and a thirdsection 967 c. Thus, as seen in FIGS. 34-37, pulling a cable 950attached to cam 961 in the direction indicated by arrow A causes camtrack 966 to rotate in a clockwise direction about center point 965, andcam track 967 (as depicted in FIG. 37) to rotate in a counter-clockwisedirection about center point 965. Inner tube 102 is connected to innertube bracket 968, which is provided with a first cam follower 969 thatis constrained to ride in cam track 967 of cam 961. Pull tube 352 isconnected to pull tube bracket 970, which is provided with a second camfollower 971 that is constrained to ride in cam track 966 of cam 961. Asa result, rotation of cam 961 will cause the brackets 968, 970 tolinearly move inner tube 102 and pull tube 352, as shown in FIGS.33A-33C.

To allow rotation of front-end portion 960 relative to applicator 100and expander 350, special connections are provided between pull tube 352and pull tube bracket 970 and between inner tube 102 and inner tubebracket 968. More specifically, pull tube 352 is provided with a disk972 at or near the proximal end of pull tube 352. Pull tube bracket 968is affixed to pull tube disk 972 to prevent relative movement betweenpull tube bracket 968 and pull tube disk 972 in a longitudinaldirection, but to allow relative rotational movement between pull tubebracket 968 and pull tube disk 972. Similarly, inner tube 102 isprovided with an inner tube disk 973 at or near the proximal end ofinner tube 102. Inner tube bracket 970 is affixed to inner tube disk 973to prevent relative movement between inner tube bracket 970 and innertube disk 973 in a longitudinal direction, but to allow relativerotational movement between inner tube bracket 970 and inner tube disk973. In this manner, front-end portion 960 is permitted to freely rotaterelative to applicator 100 to thereby allow front-end portion 960 to bepositioned at a variety of different orientations relative to applicator100.

Referring to FIG. 32, it is shown that housing 964 includes a step 974for holding outer tube 104 in place against the pulling and expansionforces exerted during the anastomosis procedure. Outer tube 104 mayinclude an outer tube disk 975 for resting against step 974.

Referring to FIGS. 33A-33C and 34-37, the operation of the currentembodiment is depicted. A user can impart a pulling motion on cable 950(FIG. 36) by squeezing grips 921, 922 of a handle portion 920 (FIG.52A). The initial pull of cable 950 moves the parts of front-end portion960 from the initial state shown in FIG. 33A, where cam follower 969resides within section 967 a (FIG. 37) and cam follower 971 resideswithin section 966 a (FIG. 35), to an expansion state shown in FIG. 33B,where cam follower 971 resides within section 966 b at a position wherethe distance x₂ between cam track 966 and the perimeter of cam 961 isgreater than the distance x₁ between cam track 966 and the perimeter ofcam 961 at position 966 a. During this initial movement, rotation of cam961 causes bracket 970 and hence pull tube 352 to move proximallyrelative to outer tube 104 from the position of FIG. 33A to the positionof FIG. 33B thereby expanding connector 200. During this movement, camfollower 969 has not reached second section 967 b of cam track 967, andas a result, both inner and outer tubes 102, 104 are held stationary. Adwell in cam 961 can be designed prior to movement from the initialstate to the expansion state so as to allow for bracket clearance andkinking in cable 950.

As the user continues to pull on cable 950, cam 961 continues to rotatecausing inner tube cam follower 971 to enter second section 967 b of camtrack 967 and pull tube cam follower 969 to travel farther along secondsection 966 b of cam track 966, at which point front-end portion 960moves from the expansion state to the compression state. As a result,both pull tube 352 and inner tube 102 simultaneously move proximallyrelative to outer tube 104, thereby compressing connector 200 betweeninner tube 102 and outer tube 104. Pull tube 352 is moved proximallywith inner tube 102 to ensure that connector 200 is maintained in itsexpanded condition as connector 200 is compressed between inner tube 102and outer tube 104.

As cable 950 is further pulled, cam 961 continues to rotate until innertube cam follower 971 enters third section 967 c and pull tube camfollower 969 travels farther along section 966 b of cam track 966, atwhich time pull tube 352 and inner tube 102 simultaneously move distallyrelative to outer tube 104, thereby releasing connector 200 from slots128, 138 of inner and outer tubes 102, 104. Finally, as cable 950 isfurther pulled, pull tube cam follower 969 enters third section 966 c,at which point pull tube 352 is moved distally with respect to the innerand outer tubes 102, 104, thereby unexpanding inner and outer tubes 102,104.

The use of dual cam 961 converts a cable pull motion into a series ofmotions: first moving inner tube 102 proximally to cause connector 200to expand; then moving both inner tube 102 and pull tube 352 proximallyto compress connector 200; then followed by moving both inner tube 102and pull tube 352 distally to release connector 200 from slots 128, 138;and finally moving pull tube distally to unexpand inner and outer tubes102, 104.

Dual Spring Actuation

The second type of drive mechanism is a dual-spring mechanism. Thismechanism has two features that allow for precise and adjustable controlover the amount of connector expansion and the amount of compression ofthe staple elements of the connector. The dual-spring device relies onstored energy to return the inner tube and pull tube to their initialpositions. The dual-spring mechanism generally requires a pull andrelease actuation source. Radial expansion of the connector is dictatedby the gap between an expansion disk and the fingers on the front-endbracket. The distance between the compression disk and the interiorshoulders on the turn grip determines the amount of compression of thestaple elements.

Referring now to FIG. 38, there is shown a dual-spring hydraulicactuator 670 in accordance with the present invention. Similar hydraulicactuators can be used to pull a cable connected to an expander, buthydraulic actuator 670 shown in FIG. 38 operates applicator 100 in adifferent manner than other hydraulically actuated embodiments describedbelow. More particularly, in the embodiment of FIG. 38, hydraulicactuator 670 is capable of separately moving expander 300 and inner tube102. Expander 300 may be directly connected to a first movable section672 (which may be a piston) via a rod 674. Preferably rod 674 isconnected to expander 300 by a threaded connection 316. Hydraulicactuator 670 is also connected to, or engaged with, inner tube 102 ofapplicator 100 via second movable section 676 (which may also be apiston) at location 675. As a result, hydraulic actuator 670 is capableof directly moving both inner tube 102 and expander 300.

The embodiment of FIG. 38 employs differential spring force to obtainthe required movements of expander 300 and inner tube 102 from a singleinjection of hydraulic fluid. More specifically, first movable section672 is connected to second movable section 676 via a first spring 678and first movable section 672 is mounted to be freely movable relativeto housing 680 by a series of fluidly sealed mounts 682. Second movablesection 676 is positioned for free movement within housing 680 but isbiased distally relative to outer tube 104 by the force of second spring684 mounted against a lower surface 686 of housing 680. Second spring684 exerts a stronger downward force than first spring 678 whenhydraulic actuator 670 is in its initial position.

In operation, hydraulic fluid is injected via inlet 686 into fluidchamber 688 of housing 680. The hydraulic fluid exerts an upward forceagainst contact surface 690 of first movable section 672 to move firstmovable section 672 proximally relative to outer tube 104, which pullsexpander 300 proximally to thereby expand applicator 100. Proximalmovement of first moveable section 672 also compresses first spring 678until the proximal force of compressed first spring 678 equals thedistal force applied by second spring 684 at which point theintermediate state is reached.

Once the proximal force of compressed first spring 678 equals or exceedsthe distal force of second spring 684 the proximal movement of firstmovable section 672 is transferred via first spring 678 to secondmovable section 676. This results in proximal movement of both expander300 and inner tube 102 to expand connector 200. Hydraulic fluidcontinues to be injected at the same rate until the release state isreached. The release state is reached when the proximal force exerted bythe hydraulic fluid on contact surface 690 equalizes with the combineddistal force exerted by compressed first and second springs 678, 684. Atthis point, the hydraulic fluid is discharged and hydraulic actuator 670returns to its final (and original) position by first uncompressinginner tube 102 and outer tube 104 by moving expander 300 and inner tube102 distally relative to outer tube 104, and then unexpanding inner tube102 and outer tube 104 by moving expander 300 distally relative to outertube 104. Surfaces 692 and 694 of housing 680 ensure that hydraulicactuator 670 returns to a consistent position in the final state.

Referring to FIGS. 39A-39C, there is shown the operation of a devicesimilar to the device of FIG. 38, the only exception being that thehydraulic fluid is replaced by pulling a cable 696 to move first movablesection 672. A significant advantage of the embodiment of FIGS. 39A-39Cis that the arrangement shown, due to its radial symmetry, does notconstrain rotation of applicator 100 relative to the actuator and thus,the user has a greater degree of freedom in positioning the actuatorrelative to applicator 100 for difficult to reach anastomosis sites. Inthis embodiment, applicator 100 can rotate 360 degrees relative to theactuator. In a preferred embodiment, a locking mechanism or frictionalresistance can be employed to hold applicator 100 in a specific positionrelative to the actuator once the desired anastomosis site is selected.Such a locking mechanism or frictional resistance may be employed in anyof the embodiments of the invention that permit free rotation of theactuator relative to the applicator, for this purpose.

Referring now to FIGS. 40A-40C, there is shown the movement of a dualspring single lever straight cam actuator 750. Actuator 750 isessentially the same as actuator 670 of FIG. 38, except that a singlelever straight cam is employed to provide the distal movement of firstmovable portion 752 of the actuator 750, rather than the use ofhydraulic fluid as in the embodiment of FIG. 38.

To provide the distal movement of first movable portion 752, the singlelever straight cam actuator 750 employs a lever 754 connected to firstmovable portion 752. Lever 754 is pivotally mounted at pivot point 756and includes a cam follower 758 adapted to follow cam track 760. Camtrack 760 is attached to a cable 762.

To go from the initial state of FIG. 40A to the expanded state of FIG.40B, cam track 760 is pulled proximally relative to cable 762 to causecam follower 758 to move the proximal side of lever 754 downwardly. Dueto the pivotal mounting of lever 754 at pivot point 756, this motioncauses the distal side of lever 754 to move upwardly, thereby pullingfirst movable portion 752 proximally relative to outer tube 104 againstthe force of first spring 678. At this position, pull tube 352 is drawnback proximally relative to outer tube 104. As cam track 760 is movedfurther proximally relative to cable 762, actuator 750 moves from theexpanded state of FIG. 40B to the compression state of FIG. 40C, therebycausing first movable portion 752 to again move proximally relative toouter tube 104. This movement, in turn, causes second movable portion676 to move proximally relative to outer tube 104 by virtue of theconnection of the first and second movable portions via first spring678. To return to the final state, cam track 760 is moved back to thedistal or initial position shown in FIG. 40A, thereby firstuncompressing inner tube 102 and outer tube 104 by moving expander 300and inner tube 102 distally relative to outer tube 104, and thenunexpanding inner tube 102 and outer tube 104 by moving expander 300distally relative to outer tube 104. This type of cam and lever actuatorcan be adapted for use with any of the other embodiments of theinvention described above by a person of ordinary skill in the art.

Referring now to FIG. 41 there is shown a cutaway view of anotherembodiment of a dual-spring actuator 1750 in accordance with the presentinvention. The dual-spring applicator 1750 includes a housing 1752.Radial expansion of the connector 200 is dictated by movement of anexpansion disk 1754 and fingers 1756 on the front-end bracket 1758. Theamount of staple finger compression is determined by the distance 1760,shown in FIG. 42A, between the compression disk 1762 and interiorshoulders 1764 on the turn grip 1766 of housing 1752.

Compression disk 1762 is threaded onto a proximal portion of inner tube102. Front-end bracket 1758 is threaded onto a proximal portion ofexpander rod or tube 312 a. The expansion disk 1754 is connected to thecompression disk 1762. A pre-tensioned spring 1768 rests between theinside face of the compression disk 1762 and an interior wall in turngrip 1766. As the front-end bracket 1758 translates proximally, theexpander rod or tube 312 a will move with it. After connector 200 isfully expanded by movement of distance 1770 shown in FIG. 42B, fingers1756 on the front-end bracket 1758 contact expansion disk 1754. Oncethis occurs, inner tube 102 move in tandem with expander rod or tube 312a (and front-end bracket 1758) and translate until compression disk 1762contacts shoulders 1764 of turn grip 1766, at which time compression ofthe connector 200 is complete.

The full movement sequence of the embodiment of FIG. 41 is shown inFIGS. 43A-43D. FIG. 43A shows the initial position of applicator 1750.FIG. 43B shows the connector expansion step. FIG. 43C shows theconnector compression step and FIG. 43D shows the applicator returned toits initial position.

For optimal maneuverability under port access conditions, and especiallywhen working transvascularly, the activating mechanism should be assmall as possible, preferably built within a catheter tip. One way torealize this is the device 1500 shown in FIG. 44, which effects thedesired sequence of first expanding the anvils to a larger diameter, andthen moving together the paired anvils by simply pulling rod 1502.Device 1500 includes an outer tube having a bore and has a diaphragm1508 disposed therein, an inner tube 102 having a bore and beingdisposed within the bore of outer tube 104, and a pulling rod 1502disposed within the bore of inner tube 102 and outer tube 104. Pullingrod 1502 includes an expansion cone 1504 on the distal end and a ring1506 fixed more proximally. A primary, relatively weak spring 1510 isdisposed between ring 1506 of pulling rod 1502 and diaphragm 1508 ofouter tube 104. A secondary, larger and stronger spring 1512 encirclesprimary spring 1510 and is disposed between the back end of inner tube102 and diaphragm 1508 of outer tube 104.

In operation device 1500 works as follows. Pulling central rod 1502relative to outer tube 104 initiates compression of primary spring 1510.The stiffness of secondary spring 1512 is chosen in such a way thatinner tube 102 remains at the same position relative to outer tube 104.Inner tube 102 and outer tube 104 and connector 200 start to expand.When expansion cone 1504 reaches a certain locking position with innertube 102, the secondary spring 1512 will start to be compressed. Theforce required to pull the central rod 1504 will of course increase.Now, expansion cone 1504 together with the inner tube 102 will startmoving relative to the outer tube 104, and the joining means, e.g.staples, clips or the like, of connector 200 will be deformed, while theexpanded state is maintained. After thus deploying connector 200,central rod 1502 is released. Consequently, first the anvils will moveto their starting positions and finally the primary spring 1510 willreverse the expansion, permitting withdrawal of device 1500.

It will be understood that the mechanism can take differentconfigurations, while still relying on the same principles. For example,device 1500 can be adapted in such a way that springs 1510 and 1512 arenot positioned concentrically, but serially, or in another, differentposition. Also, the axial force in the distal direction, generated bythe elastic deformation of inner tube 102 upon expansion, can be usedinstead of spring 1510. Ring 1506 and spring 1510 can thus be omittedwithout compromising functionality. Also, by tailoring thecharacteristics of spring 1510, other sequences of anvil expansion andmoving the paired anvils towards each other can be effected, if desired.

Single-Cam/Single-Spring Actuation

A feature of this actuation mechanism is that it allows for precise andadjustable control of the amount of connector expansion. The cam trackguides the pull tube from its initial position, to the expansion andcompression positions, and back to its initial position, without the useof stored energy. The single-cam/single-spring actuation devicegenerally requires a continuous pull from an actuation source foroperation.

The sequence of radial expansion of the connector followed by axialcompression of the staple elements is governed by the amount of gapbetween the inner tube disk and the pull tube bracket, as well as thegeometry of the cam track. The inner tube disk may be threaded onto thepull tube. A pre-tensioned spring rests between the inside face of theinner tube disk and an interior wall in the turn grip. Both sides of thecam have the same cam track in this device. The bosses on the bracketare constrained to follow the cam tracks. As the cam rotates, thebracket translates and pulls the pull tube with it. After the connectorhas expanded, the fingers on the bracket come in contact with theshoulder on the inner tube disk to cause the inner tube to move intandem with the pull tube. The geometry of the turn grips and the pulltube bracket permit the front end to articulate. The dwell in the camallows for bracket clearance and kinking in the cable.

Referring now to FIG. 45, there is shown a cutaway view of asingle-spring actuator 730 in accordance with the present invention. Thesingle-spring actuator 730 includes a housing 732 connected to outertube 104 of applicator 100. Located within housing 730 is a firstmovable portion 734 which is attached to expander 350. Also locatedwithin housing 730 is a second movable portion 736 which is attached toinner tube 102. A spring 738 having a predetermined strength is locatedwithin housing 732 and mounted to resist upward movement of secondmovable portion 736 by virtue of contact between upper contact surface740 of second movable portion 736 and the lower surface of spring 738.

The single-spring actuator 730 of FIG. 45 is shown in the initial state.To go from the initial state to the intermediate state, a proximallydirected force is exerted on connection means 735 of first movableportion 734 by any suitable method. The method shown is a lever 742.Initial proximal movement relative to outer tube 104 of connection means735 will pull only expander 350 proximally since first movable portion734 moves proximally through chamber 731 until upper contact surface 733of first movable portion 734 contacts lower contact surface 737 ofsecond movable portion 736. At this point, applicator 100 is in theintermediate state.

To go from the intermediate state to the deployed state, connectionmeans 735 is pulled further proximally causing further proximal movementof first movable portion 734. By virtue of the contact between contactsurfaces 733, 737, first movable portion 734 pulls second movableportion 736 proximally relative to outer tube 104 to the deployed statethereby compressing spring 738 by virtue of surface 740. Second movableportion 736 is, in turn, connected to inner tube 102 and thus theproximal movement of second movable portion 736 causes proximal movementof inner tube 102 relative to the outer tube 104 (which is mounted tohousing 732). The deployed state is reached when either the proximalforce on pull rod 742 equalizes with the distal force exerted by spring738, the spring is fully compressed, or a stop is reached.

To return from the deployed state to the final state, connection means735 is returned to its distal position, either by an external force orby removing the proximal force. In a preferred embodiment, surface 739of second movable portion 736 returns to its original position incontact with housing 732 by way of the distal force supplied by spring738 acting upon surface 740. In this way, surfaces 733 and 737 maintaincontact and first movable portion 734 and second movable portion 736,and correspondingly expander 350 and inner tube 102, return to theintermediate state in unison. Continued distal movement of connectionmeans 735 under an external force causes first movable portion 734 tomove through chamber 731 in second movable portion 736 until firstmovable portion contacts surface 740, at which point expander 350 andinner tube 102 are restored to their original positions. The relativedistances moved by expander 350 and inner tube 102 are set by therelative locations of the contact surfaces involved.

Activation Mechanism

As discussed above, connector 200 is deployed via two systems, theactivation mechanism and the drive mechanism or actuator. The activationmechanism translates an input energy into a motion that drives the drivemechanism. The input energy may be any type known to one skilled in theart, and can include mechanical, hydraulic, pneumatic, electrical, orany other suitable energy. Preferably, the activation mechanismtranslates the input energy into either a pulling motion or a pullingand then a releasing motion that drives the drive mechanism. Differenttypes of activation mechanisms are depicted graphically in FIGS. 46-51.Specific embodiments of activation mechanisms or handles are depicted inFIGS. 52-54 and 55-58.

Referring now to FIGS. 46A-46D, there is shown a spring driven activator400 for providing the required movements to expander 350 using a cable402 connected to the proximal end of expander 350 using, for example, athreaded screw 338. In the ready state of FIG. 46A, a compression spring404 is connected to cable 402. Compression spring 404 is undercompression against surface 406 on one side, and is held undercompression by first motion switch 408 holding cable 402 in position byany suitable mechanical means. The entire activator 400 may be anchoredin a fixed position at 410.

To go from the initial state of FIG. 46A to the intermediate state ofFIG. 46B and thereby cause expansion of inner tube 102, the userdepresses first motion switch 408 in the direction of arrow 412 of FIG.46A from the position shown in FIG. 46A to the position shown in FIG.46B. Depression of first motion switch 408 releases cable 402 to permitthe force of compression spring 404 to pull cable 402 a limited distanceproximally as shown in FIG. 46B. Once the forces equalize, proximalmotion stops and activator 400 reaches the intermediate state of FIG.46B. To go from the intermediate state to the release state, secondmotion switch 414 is depressed against spring 416 as shown in FIG. 46Bto release the force on surface 406 and thereby permit compressionspring 404 to pull cable 402 further proximally to the position shown inFIG. 46C. Second motion switch 414 achieves this by restricting themotion of bar 418 until second motion switch 414 is depressed. Secondmotion switch 414 returns to its original position in the release stateshown in FIG. 46C by virtue of the action of spring 416 for the purposeof locking bar 418 in a fixed position.

Cable 402 is then released back to the final state by the action ofrelease mechanism 420. More specifically, release mechanism 420 ispivotally connected to plate 407 at pivot point 421. Release mechanism420 is also attached to cable 402 by protrusion 422 as shown in FIG.46A. Release mechanism 420 includes an inclined surface 424 whichinteracts with inclined surface 426 of mechanical stop 428 as shown inFIG. 46C to cause protrusion 422 to release cable 402 and allow cable402 to return to the final state shown in FIG. 46D, at which pointexpander 350 and inner tube 102 return to their original positions.

Referring now to FIGS. 47A-47C, there is shown another embodiment of anactivator 500 which employs two hinged arms 504 and 506 to generate therequired motion of expander 350 using a cable 502 connected to theproximal end of expander 350 by, for example, a threaded screw 338. Inthis embodiment, cable 502 is held under tension by hinged arms 504, 506in the ready state via the connection of release mechanism 508 to cable502 via protrusion 510, and the pivotal connection of release mechanism508 to piston 512 at pivot point 511. Piston 512 is, in turn, pivotallyconnected to hinged arms 504, 506 by pivotal connections 514, 516.Hinged arms 504, 506 also include pivotal connections 524 and 526 andare also pivotally connected to a fixed housing 528 by pivotalconnections 530, 532. Housing 528 may be fixed at anchor point 534.

First motion switch 518 holds cable 502 in position in the initial stateof FIG. 47A. Depression of first motion switch 518 in the direction ofarrow 520 of FIG. 47A releases cable 502 and allows the tension exertedby hinged arms 504, 506 to pull cable 502 a short distance proximally tothe intermediate state of FIG. 47B.

To go from the intermediate state of FIG. 47B to the final state of FIG.47C, force is exerted at pivotal connections 524 and 526 in thedirection shown by arrows 536, 538 in FIG. 47B either directly by theuser or via a suitable mechanical, electrical or other device which canbe actuated by the user. The exertion of force at pivotal connections524, 526 causes hinged arms 504, 506 to fully extend to the positionshown in FIG. 47C. Initially, extension of hinged arms 504, 506 pullscable 502 further proximally until inclined surface 509 of releasemechanism 508 contacts inclined surface 540 of stop mechanism 542. Atthat point, release mechanism 508 is caused to disengage from cable 502,at which point cable 502 returns to its original position shown in FIG.47C. In this embodiment, release mechanism 508 also includes a lockmechanism 544 which engages with stop mechanism 542 as shown in FIG. 47Cto prevent piston 512 from moving distally to its original position whencable 502 moves distally.

Referring now to FIGS. 48A-48C, there is shown yet another embodiment ofan activator 550 in accordance with the present invention which employsa single hinged arm to generate the required motion of expander 350 byvirtue of pulling a cable 552 which may be connected to the proximal endof expander 350 by, for example, a threaded screw 338. In thisembodiment, cable 552 is held under tension by hinged arm 554 in theready state via the connection of release mechanism 558 to cable 552 viaprotrusion 560, and the pivotal connection of release mechanism 558 topiston 562 at pivot point 557. Piston 562 is, in turn, pivotallyconnected to hinged arm 554 by pivot 556. Hinged arm 554 also includespivot 564 and is also pivotally connected to housing 566 at pivot 568.Housing 566 may be fixed at anchor point 570.

First motion switch 572 holds cable 552 in position in the initial stateof FIG. 48A. Depression of first motion switch 572 in the direction ofarrow 574 of FIG. 48A releases cable 552 and allows the tension exertedby hinged arm 554 to pull cable 552 a short distance proximally to theintermediate state of FIG. 48B.

To go from the intermediate state of FIG. 48B to the final state of FIG.48C, force is exerted on arm extension 576 of hinged arm 554 in thedirection of arrows 578 in FIG. 48B either directly by the user or via asuitable mechanical, electrical or other device which can be actuated bythe user. The exertion of force on arm extension 576 causes hinged arm554 to extend to the position shown in FIG. 48C. Initially, extension ofhinged arm 554 pulls cable 552 further proximally until inclined surface559 of release mechanism 558 contacts inclined surface 580 of stopmechanism 582. At that point, release mechanism 558 is caused todisengage from cable 552, at which point cable 552 returns distally tothe position of the final state shown in FIG. 48C. In this embodiment,release mechanism 558 also includes a lock mechanism 584 which engageswith stop mechanism 582 as shown in FIG. 48C to prevent piston 562 frommoving back distally to its original position when cable 552 movesdistally to the final state.

Referring now to FIGS. 49A-49D, there is shown another embodiment of anactivator 600 in accordance with the present invention which employs afreewheel 604 to generate the required motion of expander 350 by virtueof pulling a cable 602 which may be connected to the proximal end ofexpander 350 by, for example, a threaded screw 338. In this embodiment,cable 602 is held under tension to freewheel 604 in the ready state viathe connection of release mechanism 608 to cable 602 via protrusion 610,and the pivotal connection of release mechanism 608 to freewheel 604 atpivot point 606. Freewheel 604 is biased to rotate in a clockwisedirection in FIGS. 49A-49D by, for example, a spring (not shown).

Freewheel 604 is initially held in position by motion switch 612 in theinitial state of FIG. 49A by engagement of the ready switch 612 withboth freewheel 604 and housing 616. Housing 616 may be fixed byanchoring it at anchor point 618. Depression of motion switch 612 in thedirection of arrow 614 of FIG. 49A releases cable 602 and allows thetension exerted by spring-loaded freewheel 604 to pull the cable 602 ashort distance proximally to the intermediate state of FIG. 49B byrotation of freewheel 604 in a clockwise direction.

To go from the intermediate state of FIG. 49B to the release state ofFIG. 49C, force is exerted by the user on freewheel 604 in the directionof arrow 619 of FIG. 49B to cause further clockwise rotation offreewheel 604 to the release state of FIG. 49C to thereby cause cable602 to move further proximally. Force 619 can be exerted either directlyby the user or via a suitable mechanical, electrical or other devicewhich can be actuated by the user.

To go from the release state of FIG. 49C to the final state of FIG. 49D,the user continues to exert force in the direction of arrow 619 to causefurther clockwise rotation of freewheel 604. Further rotation offreewheel 604 causes inclined surface 609 of release mechanism 608 tocontact inclined surface 620 of stop mechanism 622. At that point,release mechanism 608 is caused to disengage from cable 602 by pivotingabout pivot point 610 at which point cable 602 returns distally to theposition of the final state shown in FIG. 26D. In this embodiment,housing 616 preferably includes a mechanical stop 624 to prevent motionswitch 612 and thus freewheel 604 from rotating in a clockwise directionbeyond the position reached in the final state of FIG. 49D.

Referring now to FIGS. 50A-50C, there is shown another embodiment of anactivator 630 in accordance with the present invention which employsfreewheel 634 to generate the required motion of expander 350 by virtueof pulling cable 632 which may be connected to the proximal end ofexpander 350 by, for example, a threaded screw 338. In this embodiment,cable 632 is held under tension to freewheel 634 in the initial statevia the connection of cable 632 to cam follower 636 located in cam 638of freewheel 634. Freewheel 634 is biased to rotate in a clockwisedirection in FIGS. 50A-50C by, for example, a spring (not shown).

Freewheel 634 is held in position by motion switch 642 in the initialstate of FIG. 50A by engagement of motion switch 642 with both freewheel634 and housing 646. Housing 646 may be fixed by anchoring it at anchorpoint 648. Depression of motion switch 642 in the direction of arrow 644of FIG. 50A releases cable 632 and allows the tension exerted byspring-loaded freewheel 634 to pull cable 632 a short distanceproximally to the intermediate state of FIG. 50B by rotation offreewheel 634 in a clockwise direction as shown by arrow 649. Rotationof freewheel 634 pulls cable 632 by movement of cam follower 636 in cam638 of rotating freewheel 634. The initial movement of the cam follower636 in cam 638 pulls cable 632 over mechanical stop 647 which isattached to housing 646, thereby moving cable 632 a short distanceproximally as shown in FIG. 50B.

To go from the intermediate state of FIG. 50B to the final state of FIG.50C, cam follower 636 reaches a point shown in FIG. 50B where thetension on cable 632 will cause cam follower 636 to continue movementalong cam 638 and cause further rotation of freewheel 634 in a clockwisedirection to the position of FIG. 50C. Due to the nature of cam 638,cable 632 returns to the final state shown in FIG. 50C by the action ofcam follower 636 following cam 638. Mechanical stop 647 extendsdownwardly as shown in the figures to prevent motion switch 642, andthus freewheel 634, from rotating in a clockwise direction beyond theposition reached in the final state of FIG. 50C.

Referring now to FIGS. 51A-51D, there is shown another embodiment of anactivator 650 in accordance with the present invention which employs afreewheel 654 to generate the required motion of expander 350 by virtueof pulling a cable 652 which may be connected to the proximal end ofexpander 350 by, for example, a threaded screw 338. In this embodiment,cable 652 is held under tension to freewheel 654 in the initial statevia the connection of cable 652 directly to freewheel 654 by a pivotalconnection 656. Freewheel 654 is biased to rotate in a clockwisedirection in FIGS. 51A-51D by, for example, a spring (not shown).

Freewheel 654 is initially held in position by motion switch 662 in theready state of FIG. 51A by engagement of motion switch 662 with bothfreewheel 654 and housing 666. Housing 666 may be fixed by anchoring itat anchor point 668. Depression of motion switch 662 in the direction ofarrow 664 of FIG. 51A releases cable 652 and allows the tension exertedby spring-loaded freewheel 654 to pull cable 652 a short distanceproximally to the intermediate state of FIG. 51B by rotation offreewheel 654 in a clockwise direction as shown by arrow 669. Rotationof freewheel 654 pulls cable 652 by movement of pivotal connection 656of rotating freewheel 654. The initial movement of pivotal connection656 pulls cable 652 a short distance proximally as shown in FIG. 51B.

To go from the intermediate state of FIG. 51B to the release state ofFIG. 51C, further rotation of freewheel 654 causes pivotal connection656 to reach a point shown in FIG. 51C where cable 652 moves distallyand returns to the final state shown in FIG. 51D. Mechanical stop 667prevents motion switch 662, and thus freewheel 654, from rotating in aclockwise direction beyond the position reached in the final state ofFIG. 51D.

In addition to the embodiments described schematically in FIGS. 46-51, arack and pinion and extension spring system may be employed to pull on acable or pulling tube 350. In this embodiment, the cable or pulling tube350 is pivotally attached to a lever, which, in turn, is pivotallyattached to a rack that is housed within a housing. A spring-loadedpinion is rotatably mounted to the housing and is provided with pinionteeth for engagement of the rack. The pinion may be held in the initialposition by any suitable mechanical or electrical actuation device. Tooperate such a rack and pinion device, the pinion is initially held in afirst position. The pinion is released, whereupon the pinion 832 rotatesand pulls the rack which, in turn, causes the cable or pull tube to moveproximally to expand the inner tube 102 and then compress connector 200.The pinion continues to rotate until the pinion teeth disengage from theteeth of rack, thereby allowing the rack and thus the cable or pull tube350 to return to its initial position. A return spring may be providedon the rack to help return the rack to its original position.

Shape Memory Mechanism

In addition to the embodiments described above, an activator can bedesigned using shape memory alloys. Shape memory alloys may be made fromnickel and titanium, an example being Nitinol. These alloys have aunique ability to contract when heated. The shape memory alloys returnto their original state upon cooling to room temperature. Thecontractibility allows the shape memory alloy wires to exert a forcethat can be exploited to drive one of the mechanisms described above, orto drive the pull tube and inner tube directly. For example, a shapememory alloy wire or an array of shape memory alloy wires could bedirectly attached to each of the inner and pull tubes. Electrical meanscould be used to heat the shape memory alloy material. The resultantdecrease in the length of the shape memory alloy of the wires would thenbe employed to independently drive the movements of the inner and pulltubes, including the movement required for deformation of the stapleelements of the connector. Since the shape memory alloy wires return totheir original length upon cooling, no additional means is required toreturn the inner and pull tubes to their original position onceanastomosis is complete. One potential advantage of the shape memoryalloy activator, is that it would permit a miniaturized or compactactivator that could be suitable for use, for example, in endoscopicprocedures.

Handles

Referring to FIGS. 52-54, there is shown details of a handle portion 920of activator 900 or 901 (FIGS. 1-2). Handle portion 920 of thisembodiment has the advantage that it provides direct, positive feedbackto the user indicative of the motions of front-end portion 960. As aresult, the user has more control of the process and can be informed ofthe current state of the anastomosis by handle portion 920.

Handle portion 920 includes two grips 921, 922 hingedly attached to oneanother at the rear 923 of handle portion 920. Handle portion 920 can befabricated to any suitable size but is preferably fabricated such thatgrips 921, 922 can each be actuated by pressure exerted by the hand ofthe user. As a result, squeezing grips 921, 922 of handle portion 920between the thumb and the middle and index finger of the user canactuate handle portion 920. Grips 921, 922 may include a roughened ortextured portion 928 on the surface thereof to facilitate gripping bythe user.

As seen in FIGS. 52A-52B grip 921 has a linkage 924 fixedly connected togrip 921 by a pivotal connection 925 which allows linkage 924 to pivotrelative to grip 921. Grip 922, has a linkage 926 fixedly connected togrip 922 by a pivotal connection 927 which allows linkage 926 to pivotrelative to grip 922. Referring to FIG. 52B, linkage 924 connects to asliding join 934 a with linkage 929 and linkage 926 connects to asliding join 934 b with linkage 930. The sliding join 934 a betweenlinkage 924 and linkage 929 is mounted for sliding movement in a slot931 of grip 922. Similarly, the sliding join 934 b between linkage 926and linkage 930 is mounted for sliding movement in a slot 932 (FIG. 53)of grip 921.

The mounting of sliding linkages in slots 931, 932 provides twoadvantages for handle portion 920. First, the movement of slidinglinkages in slots 931, 932 provides direct feedback to the userindicating the extent of movement of the applicator 100 and/or expander300 or 350 since the user can view or feel the position of the slidinglinkages in slots 931, 932 while using the activator 900 or 901. Second,the connection of linkages 924, 926, 929 and 930 to both grips 921, 922helps to ensure that both sets of linkages move together at the samepace to provide a consistent motion of the various moving parts ofactivator 900. Such a movement is ensured because the connection oflinkages 924, 926, 929 and 930 to both grips 921, 922 require that grips921, 922 move together simultaneously and will thereby substantiallyprevent movement of one of grips 921, 922 without corresponding movementof the other of grips 921, 922.

Referring to FIG. 52B, linkages 929, 930 are mounted on a slidablelinkage 933, which also requires linkages 929, 930 to move together as aunit. Slidable linkage 933 is fixedly mounted in rear shuttle 935.Handle portion 920 includes a front shuttle 936 in addition to rearshuttle 935. Rear and front shuttles 935, 936 together form areciprocating element which is capable of reciprocating motion withinhandle portion 920. Front shuttle 936 is connected to rear shuttle 935by a spring 941 which permits a slight separation between front shuttle936 and rear shuttle 935 for the purpose of absorbing slack in thesystem. In this manner, a smooth even pull of cable or pull tube 352 canbe ensured even though handle portion 920 may be connected via aflexible connection 903 to front-end portion 960.

Handle portion 920 may also include a leaf spring ratchet as shown inFIG. 52C connected to spring 941 and composed of a track 937 and anengagement device 938 which rides in track 937 to ensure one-waymovement of the cable or pull tube. Engagement device 938 of the leafspring ratchet is located in a fixed position except that engagementdevice 938 has the ability to move up and down to slide along track 937.As the rear shuttle portion 935 slides proximally as shown in FIGS.53-54, track 937, which is part of rear shuttle portion 935, also slidesproximally allowing engagement device 938 to ride up slopes 939 of track937 until engagement device 938 reaches the proximal-most edge of thenext slope 939 and drops into one of the slots 940 of track 937. Thedropping of engagement device 938 into a slot 940 in track 937 preventsthe rear shuttle 935 from moving distally during the anastomosisprocedure and thus prevents a reversal of the motion of cable or pulltube 352 in the middle of the procedure in the event the user stops theapplication of force to handle portion 920 for any reason. This ratchetfeature allows the user to hand handle portion 920 to another personduring the procedure, for example.

Handle portion 920 is connected via connection 902, 903 to front-endportion 960 as shown in either FIG. 1 or FIG. 2. A cable 950, shown inFIG. 36, connects front shuttle 936 of handle portion 920 to cam 961 offront-end portion 960. As shown in FIG. 36, cable 950 is positionedinside a slot 962 in cam 961 in such a manner that pulling on cable 950will cause rotation of cam 961 through an arc of preferably about 100degrees. The end 951 of cable 950 is fixed in hole 963 in cam 961. Thisarrangement allows remote actuation of front-end portion 960 by handleportion 920 in, for example, the embodiment of FIG. 2.

Referring now to FIGS. 55A-55B, there is shown an alternative embodimentof an activator 1600 which employs a squeeze and release design. Asshown in FIGS. 55A-55B, activator 1600 includes a lever 1602, a link1604, a sheath 1606 and a housing 1608. The interior parts of activator1600 of FIGS. 55A-55B are shown in FIGS. 56A-56E.

The handle of activator 1600 is designed for actuation by a singlesqueeze and release to accomplish all of the necessary motions tocomplete an anastomosis. In a preferred embodiment, activator 1600 isdesigned for use with a dual-spring mechanism to pull cable 1620 apredetermined distance and then permit cable 1620 to return to itsinitial position by releasing cable 1620.

Referring to FIG. 57A, which shows the initial position of activator1600, it can be seen that cable 1620, which extends through sheath 1606,includes a crimp 1622. A gap 1624 exists between crimp 1622 and asurface 1613 of a movable body portion 1611 when activator 1600 is inthe initial position of FIG. 57A. The gap 1624 allows for relativemotion between the crimp 1622 and surface 1613 that occurs when flexiblesheath 1606 is bent during normal use. Bending sheath 1606, whichcontains cable 1620, causes relative motion between the two components.Gap 1624 prevents the relative motion between the cable 1620 and sheath1606 from initiating the actuation of the drive mechanism beforesqueezing the levers 1602 of the handle. Thus, the initial squeeze oflevers 1602 closes gap 1624 between surface 1613 and crimp 1622 by thepushing force exerted by links 1626, 1628 against the surface 1615 ofbody portion 1611 to move body portion 1611 to the position shown inFIG. 57B. As a result of the movement of body portion 1611 proximallyfrom the position of FIG. 57A to the position of FIG. 57B, feet 1617 oflegs 1612 of body portion 1611 move relative to ratchet 1610, as shown.Ratchet 1610 prevents body portion 1611 from moving back distally sincefeet 1617 (FIG. 56D) of body portion 1611 engage with teeth 1609 ofratchet 1610. Once gap 1624 is closed, the pulling force exerted on bodyportion 1611 will be transferred to cable 1620 via surface 1613 of bodyportion 1611. Legs 1612 will flex in, and allow feet 1617 to ride onteeth 1609 of ratchet 1610 during closure of levers 1602.

Continuing to squeeze levers 1602 moves activator 1600 from the positionshown in FIG. 57B to the position shown in FIG. 57C. During this phaseof actuation, fulcrum points 1627, 1629 (FIG. 57C) on links 1626, 1628engage with body portion 1611 to cause links 1626, 1628 to be deflectedfrom a position parallel to body portion 1611, as shown in FIG. 57B, toa position at an angle to body portion 1611, as shown in FIG. 57C. Thisdeflection of links 1626, 1628 causes links 1626, 1628 to ride up onsurface 1615 of fins 1619 of body portion 1611 to an intermediateposition shown in FIG. 57C, while at the same time exerting a furtherforce on surface 1615 of body portion 1611 to continue movement of bodyportion 1611 proximally. Legs 1612 continue to flex inwardly to allowfeet 1617 to continue to ride on teeth 1609 of ratchet 1610 during thisphase of movement.

The final phase of actuation causes movement of activator 1600 to theposition shown in FIG. 57D. As can be seen from FIG. 57D, body portion1611 has traveled further proximally from the position shown in FIG. 57Cand links 1626 and 1628 have ridden further along surface 1615 of bodyportion 1611 to allow levers 1602 to be fully closed. In the position ofFIG. 57D, legs 1612 and feet 1617 of body portion 1611 have come free ofratchet 1610. Since legs 1612 were biased inwardly by ratchet 1610 whileriding in ratchet 1610, once legs 1612 are free of ratchet 1610 theyexpand freely to a width that exceeds the width of ratchet 1610, asshown in FIG. 57D. This action permits activator 1600 to be returned tothe initial position of levers 1602 since feet 1617 of legs 1612 can nowride on smooth outer surfaces 1605, 1607 of ratchet 1610 and thus feet1617 will not engage with teeth 1609 of ratchet 1610 during the returnmovement. This permits the user to simply let go of the levers 1602 torelease the device.

Return relies on the compression in the sheath 1606 and loads from thefront-end mechanism. Specifically, sheath 1606 may be a relativelyrigid, but compressible material such that sheath 1606 essentiallymaintains the spacing between the activator 1600 and a dual-springmechanism employed to maintain tension on cable 1620. Sheath 1606 alsohas some compressibility to take up some excess travel of cable 1620since at a certain point, depending on the initial bend in the sheath1606, sheath 1606 will compress before cable 1620 can travel anyfurther. In this arrangement, sheath 1606 functions similar to arelatively rigid spring.

FIG. 58 shows a single squeeze mechanism which allows the links 1626,1628 to release from surface 1615 of body portion 1611. Moreparticularly, the portion of links 1626, 1628 that engages surface 1615of body portion 1611 rides to a location beyond the end of surface 1615as shown in FIG. 58 so that body portion 1611 is no longer engaged withlinks 1626, 1628. As a result, body portion 1611 is permitted to returnto the starting position as a result of the force in the compression ofthe sheath 1606. This embodiment employs thinner fins 1619 a than thefins 1619 of the embodiment of FIGS. 55A-57D such that the body portion1611 is free to return to the starting position.

The various embodiments of the devices of the present inventiondescribed above, can be interchanged to provide various combinations ofthe activator, expander and applicator. Thus, different activators canbe used with different expanders and/or activators within the scope ofthe present invention and the person skilled in the art would be able toadapt a given activator for use with a particular expander orapplicator.

The use of the applicator, expander and activator of the presentinvention will now be described in relation to a pseudo end-to-sideanastomosis procedure, while keeping in mind that this procedure iseasily translated into a transluminal end-to-side or end-to-endanastomosis. What is meant by a pseudo end-to-side anastomosis is aside-to-side anastomosis, which is converted to an end-to-sideanastomosis by closing the free end of the graft, downstream of theanastomosis, as described in U.S. Pat. No. 6,485,496. Referring to FIGS.59-62, a pseudo end-to-side anastomosis procedure is depicted. In thefirst step of the procedure, applicator 100 is inserted into one end 981of vessel graft 980, shown in partial cross-section in FIG. 59.Applicator 100 is then inserted through a hole 982 in the sidewall ofgraft 980, having dimensions in a range suitable for the size ofapplicator 100, while the proximal anvils 108 remain within the lumen ofgraft 980, such that the distal end of applicator 100 with distal anvils112 protrudes from hole 982 in the sidewall of graft 980 as shown inFIG. 59. This is easily effected in a correctly sized hole, due to theelasticity of tissue, which results in a preferred position of the holearound the most slender part of applicator 100. As a result, staple-likeelements 202 of connector 200 are correctly positioned relative to theedges of hole 982 in the sidewall of graft 980.

In the next step of the process, shown in FIG. 60, the distal end ofapplicator 100 is inserted into a hole 986 in the sidewall of targetvessel 984, also having dimensions in a range suitable for the size ofapplicator 100, such that distal anvils 112 are completely inside thelumen of vessel 984. Again, as a result, staple-like elements 202 ofconnector 200 are consequently also correctly positioned relative to theedges of hole 986 in the sidewall of target vessel 984. At this point,applicator 100 is actuated to cause expansion and movement of inner tube102 relative to outer tube 104 as discussed above. The combination ofexpansion and movement of inner tube 102 causes connector 200 to pierceand engage with the sidewalls of graft vein or artery 980 and artery 984as described above. Applicator 100, in the release state, afterexpansion and staple closure of connector 200 is shown in FIG. 61. Withconnector 200 in its expanded and compressed position, a fluidconnection is created between hole 982 in the sidewall of graft vein 980and hole 986 in the sidewall of target vessel 984.

At this point, applicator 100 is removed to disengage connector 200 fromapplicator 100, and applicator 100 is removed from the anastomosis sitevia the end 981 of graft vein 980. In the final step, to complete theanastomosis, end 981 of graft vein 980 is sutured closed by sutures 988as shown in FIG. 62, or alternatively clipped together by a hemoclip, orclosed by an endoluminal plug, a suture loop or by any other means, suchas diathermia or ultrasound known in the art to reliably close a bloodvessel.

As mentioned, it will be understood that the same method can be used torealize a true end-to-side anastomosis, for example using atrans-luminal catheter-carrying device 1500 as shown in FIG. 44. In thiscase, device 1500, which is properly sized relative to the diameter ofopen end 981 of graft 980, is moved through graft 980 and positionedinside end 981, such that only the distal portion of device 1500carrying distal anvils 112 is disposed out end 981. If necessary, thediameter of open end 981 can be reduced to better fit the diameter ofapplicator 100, for example, by slightly constricting it with a anelastic band or purse-string suture, which stretches or breaks upon thesubsequent expansion. Device 1500 is then inserted into target vessel984 and actuated as described above. Using the same principles, it ispossible to create an end-to-end anastomosis with a properly dimensioneddevice like device 1500.

Internal Side-to-Side Anastomosis

Making internal side-to-side anastomosis requires two important steps:the creation of correctly sized holes in the vessels to be joined, andthe subsequent introduction in the graft and in the target vessel of thedevice. The requirement of unobstructed blood flow through the resultinganastomosis, implicating an anastomotic orifice at least equal to thecross sectional area of the target coronary after potential recoil ofthe expanded ring, as well as after being covered with neo-intima aspart of the body healing response, shows that the initial anastomoticorifice should be oversized relative to the target vessel. Thisover-sizing requirement generates additional difficulties, like the needfor a bigger size applicator in a vessel, which is consequently moredifficult to introduce. From a surgical point of view, the method shouldrequire minimal manipulation and be suitable for a reliable check ofeach subsequent step, like visual or echographic inspection to optimallyand safely suit endoscopic or combined endoscopic and percutaneoustransvascular application, or even total percutaneous application. Twodeployment methods are described below that accomplish these goals.

Semi-Axial Introduction

Semi-axial introduction is a method for achieving internal side-to-sideanastomosis. The semi-axial introduction method requires insertion ofapplicator 100, preloaded with graft 980, in an axial direction intotarget vessel 984, followed by a rotation to a substantiallyperpendicular position relative to target vessel 984. FIGS. 63A-63K showaspects of the semi-axial introduction method. FIGS. 63A and 63B showthe steps of preloading applicator 100 with graft 980. Applicator 100 isinserted into the free end 981 of graft vessel 980, after making a holeor an incision 982 in the graft. At the distal end of applicator 100 isa nosepiece 1002 and several sets of anvil pairs 108, 112, depictedschematically. A connector 200, not shown, would be located on theoutside of inner tube 102 between anvils 108 and anvils 112, as shown inother figures in the present application. Nosepiece 1002 is pressedagainst side hole 982. FIG. 63B shows nosepiece 1002 and anvils 112pushed through side hole 982. In this embodiment, nosepiece 1002 isstreamlined and conical in shape in order to facilitate pushingnosepiece 1002, distal anvils 112 and part of connector 200 through sidehole 982.

FIG. 63C shows nosepiece 1002 and applicator 100 being positionedsubstantially parallel to target vessel 984 and hole or incision 986 tothereby position connector 200 substantially parallel to the targetvessel. FIG. 63D shows nosepiece 1002 and distal anvils 112 advanced toa position whereat a portion of connector 200 is advanced into hole 986.

FIG. 63E shows applicator 100 in position for expansion and deformationof connector 200. Connector 200 is preferably actuated when it ispositioned substantially perpendicular to target vessel 984 and hole986. This requires applicator 100 to be brought from the substantiallyparallel position to a perpendicular position, relative to target vessel984. At this point, applicator 100 is actuated to expand and causemovement of anvils 112 of inner tube 102 relative to anvils 108 of outertube 104. The combination of expansion and movement of inner tube 102causes connector 200 to expand and engage the sidewalls of graft vessel980 and target vessel 984.

In order to avoid damage to the interior of target vessel 984, nosepiece1002 is movable from a first position, parallel to the axis ofapplicator 100 during insertion, to a second position, at an angle tothe axial line of applicator 100. In a preferred embodiment, duringactuation of connector 200, nosepiece 1002 separates from connector 200and remains attached to applicator 100 by a tether 1004. Tether 1004provides mobility for nosepiece 1002 thereby preventing possible damagethat may be caused during the actuation of connector 200. Tether 1004may be constructed of either an elastic string, or a spring.Alternatively, nosepiece 1002 may be attached via a non-elastic cordthat can be released before actuation of connector 200. Additionally,nosepiece 1002 can be constructed with a magnetic material and bereleased and attached to applicator 100 with magnetic force.

A potential problem with the method of rotating applicator 100 to aperpendicular position relative to the target vessel described above isthat it requires the diameter of distal portion of applicator 100 to besmaller, or at most equal to the inner diameter of the target vessel984. Otherwise, distal anvils 112 may become wedged into target vessel984 and the back wall of target vessel 984 may become stuck around thedistal end of applicator 100, as shown in FIG. 63F. This may cause theback wall of target vessel 984 to be pulled toward the upper wall oftarget vessel 984 and, as shown in FIG. 63G, through actuation ofconnector 200 become stapled to the upper wall of target vessel 984 andgraft vessel 980, thus permanently closing the target vessel in onedirection. This is undesirable, since in many situations, includingsurgical myocardial revascularization, the target vessel should be openin both directions. The described phenomenon tends to occur with largeapplicators, relative to the target vessel, and therefore interfereswith the required over-sizing of the anastomosis as described above.

One solution to the aforementioned problem is the addition of shield1006 to nosepiece 1002, shown in FIGS. 63H and 63I. As shown in FIGS.63J and 63K, shield 1006 prevents the back wall of target vessel 984from holding onto distal anvils 112 by holding the vessel wall away fromdistal anvils 112.

To prevent nosepiece 1002 from becoming wedged within target vessel 984and therefore complicating withdrawal, radius R₁ of nosepiece 1002 inthe area of the rounded front portion 1008 of applicator 100 may bereduced in relation to the radius R₂ of the nosepiece 1002 in the areaof the shield 1006, thereby resulting in an oval cross-section ofnosepiece 1002, shown, for example, in FIG. 63H. Alternatively,nosepiece 1002 may have other means to reduce its diameter, for exampleby being deflatable, or by being deformable.

As shown in FIG. 63H, to facilitate the introduction of applicator 100into target vessel 984, applicator 100 has a rounded front portion 1008,which streamlines the overall contour of the distal end of applicator100. Nosepiece 1002 has a concave back that fits into front portion1008. Additionally, the rounded front portion 1008 facilitates thepivoting motion of the nosepiece 1002 when applicator 100 is moved tothe perpendicular position shown in FIG. 63K. As shown in FIG. 63K, whenapplicator 100 is in a perpendicular position, shield 1006 and nosepiece1002 are substantially parallel to the back end of target vessel 984.Nosepiece 1002 and shield 1006 may be connected centrally to the distalend of applicator 100 by a string or flexible tubing, which may beelastic, or a spring, in a manner similar to the tether 1004 of FIGS.63E and 63G. Alternatively, nosepiece 1002 and shield 1006 can beconnected eccentrically via a connection from the tip of shield 1006 toa suitable part of applicator 100. In such a case nosepiece 1002 can beheld in place by additional means, such as magnetic force. Additionally,connecting the nosepiece 1002 at the proximal tip of shield 1006 mayfacilitate withdrawal of applicator 100, by preventing shield 1006 fromhooking under the connector 200.

Perpendicular Introduction

Perpendicular introduction is a second method for achieving internalside-to-side anastomosis. The perpendicular introduction method requiresa motion in a direction, perpendicular to the axis of applicator 100, toinsert toe 1010 (or anvil 112 in case of absence of insertion shoe 1010)of applicator 100, which is tilted only slightly relative to the targetvessel and has been preloaded with graft 980, into hole 986 of targetvessel 984, followed by a slight rotation back to a more perpendicularposition relative to the target vessel. FIGS. 64A-64D show aspects ofthe perpendicular introduction method.

FIG. 64A shows applicator 100 inserted into the free end of graft vessel980 and pushed through side hole or incision 982 inside out. The axiallyasymmetric insertion foot 1010 shown here is optional. An applicator 100without any nosepiece or insertion foot may also be used with thistechnique. FIG. 64B shows the embodiment with an insertion shoe 1010.Insertion shoe 1010 is brought out through side hole 982 by passing outof the rounded part of shoe 1010 first.

Next, as shown in FIG. 64C, preloaded applicator 100 is brought to thetarget vessel 984 and tilted to some degree towards the toe of shoe1010. The tip of shoe 1010 is then pushed into hole 986 of target vessel984 until the anvils adjacent on that side of applicator 100 are insidethe target vessel 984.

Next, as shown in FIG. 64D, applicator 100 is tilted backwards to asubstantially perpendicular position to insert the heel of shoe 1010 andadjacent anvils on that side of applicator 100 as well. Applying sometraction on the surrounding tissue with an instrument, like a surgicalforceps, may facilitate proper introduction of applicator 100.

Using either the semi-axial introduction method or the perpendicularintroduction method, applicator 100 is activated to realize theanastomosis, and applicator 100 is subsequently withdrawn, and the freeend of graft vessel 980 is closed with suture 1011, as show in FIG. 65A,or clip 1012, as shown in FIG. 65B, or any other vessel closing means.Alternatively, an additional anastomosis can be made with the same graftfurther downstream in order to create a jump graft.

Part of the semi-axial introduction method or the perpendicularintroduction method is the proper sequence of actions during actuationof connector 200, which causes stapling or connection of the graftvessel to the target vessel. Any of the following sequences can be usedas part of the semi-axial introduction method or the perpendicularintroduction method described hereunder: first expansion of theconnector 200 via expansion, then deformation of the staples, clips orthe like to clamp graft vessel 980 and target vessel 984 together; thesimultaneous expansion and deformation of the staples, clips or the liketo connect graft vessel 980 and target vessel 984; first deformation ofthe staples, clips or the like, followed by expansion of connector 200and deformation of connector 200 without any expansion. The sequence ofexpansion first followed by deformation of connector 200 is thepreferred sequence, however, due to the increased reliability of tissuepositioning between the anvils before deformation of the connector 200,minimizing the chance of miscapture of tissue.

Also important is the precise way the tissue is engaged by connector200. Any of the following ways can be used as part of the methods:complete tissue penetration of the tips of the connecting means; partialtissue penetration; or clamping of the tissue only, without tissuepenetration. However, like hand suturing, complete tissue penetration isthe preferred way due to the increased strength of the tissue bond thatis effected, as well as the guaranteed capturing of all vessel walllayers (adventitia, media and intima), which is an important surgicalprinciple to minimize the chance of complications like tissue escape orvessel wall delamination.

Also important is the orientation of the staples, clips or the likerelative to the axis of the target vessel 984. Connectors 200 suitablefor anastomoses with coronary arteries, will often feature eight pairsof staples, clips or the like, for example staples 1014 shown in FIG.65C, spaced equally on connector 200. As discussed above, connector 200may have more or less staple elements 202, depending upon the size ofthe anastomosis. For example, for smaller vessels, connector 200 mayhave seven or less staple elements 202, or for larger vessels, connector200 may have nine or more staple elements 202. In each case, applicator100 preferably would include a number of anvils 108, 112 that correspondto the number of staple elements 202. While any orientation may lead togood results, the orientation shown in FIG. 65C with the central axis oftarget vessel 984 between two adjoining staples is the preferredposition. The orientation relative to the grafted vessel is generallyless important.

Guide Wire Methods

The semi-axial introduction method and the perpendicular introductionmethod described above is also applicable to and can benefit from guidewire methods.

Semi Axial Introduction

Preloading is done by inserting guide tube 1018, as shown in FIG. 66A,with a rounded (non-traumatic) end into the lumen of graft vessel 980through its free end. One end of guide tube 1018 is pushed against thewall of graft vessel 980 at the desired spot of the anastomosis, andstiff guide wire 1020 is advanced through guide tube 1018 and pushed topenetrate the wall of graft vessel 980 creating a hole 982. Guide tube1018 is then removed from graft vessel 980.

After removing guide tube 1018 from graft vessel 980, applicator 100 isadvanced over guide wire 1020, as shown in FIG. 65B. The applicator 100is provided with a properly dimensioned central cylindrical holeextending its entire length for accepting the guide wire. To facilitatethe advancement of applicator 100, a cutting edge 1022, as shown inFIGS. 66A and 66B, may be built into nosepiece 1002. As shown in FIG.66A, cutting edge 1022 is kept within the contour line of nosepiece1002. Consequently, cutting edge 1022 can only cut when forced through asmall hole and cannot damage the tubular inside of the target vessel984.

Alternatively, as shown in FIGS. 66C and 66D, cutting edge 1022 may bebuilt into a separate, conical rod 1024, which is advanced over guidewire 1020 to create hole 982. Rod 1024 is then removed and applicator100 is advanced over guide wire 1020. In alternative embodiments,nosepiece 1002 may be attached to applicator 100 by a thin walled,flexible tube 1028, shown in FIG. 65E. Preferably, tube 1028 extendssome distance in front of nosepiece 1002. Also, thin shield 1006, shownin FIGS. 63H and 63I, may be added to the nosepiece 1002. Cutting edge1022 may be attached to nosepiece 1002 or rod 1024. Cutting edge 1022may also be used without guide wire 1020.

Guide wire 1020 will then penetrate the wall of the target vessel 984,or be inserted into a previously made arteriotomy. Alternatively, guidewire 1020 may be removed and the applicator 100 may be advanced over asecond guide wire 1026 coming out of the target vessel 984, as shown inFIG. 66E. Second guide wire 1026 may be brought into the bloodstream ata location distant from the operative site, like a percutaneousinsertion site in the femoral artery in the groin, and be steered to thedesired spot and be made to penetrate the vessel wall there, or may bebrought into the target vessel 984 at the anticipated site of theanastomosis from the operative field, through a hollow needle or someother method to create a hole in the wall.

After usage of guide wire 1020, a device for enlarging the hole in acontrolled way is employed. In the preferred embodiment, guide rod 1024with the built in cutting edge 1022, as shown in FIGS. 66C and 66D, isadvanced over guide wire 1020 and removed thereafter.

Alternatively, as shown in FIG. 66F, applicator 100 with the nosepiece1002 is advanced over guide wire 1020 directly to enlarge hole 986during insertion, and pushed into target vessel 984 over either guidewire 1020 or guide wire 1026. As shown in FIG. 66G, guide wire 1020 ispulled back to enable the required pivoting movement of the nosepiece1022, but it remains within the distally extending flexible tubing 1028in the case of a percutaneous guide wire technique. In case stiff guidewire 1020 was brought in from the operative field, it is withdrawn intoapplicator 100. As shown in FIG. 66H, applicator 100 is then broughtinto a perpendicular position and is ready to be actuated.

Perpendicular Introduction

There are several ways to use guide wires with this insertion method.

One Wire Technique

As shown in FIGS. 67A and 67B, wire insertion shoe 1030 features achannel 1032 oriented perpendicularly to the axis of the applicator forproviding access to a guide wire 1026 that extends from target vessel984 as described above. After creating a controlled arteriotomy, forexample by advancing guide rod 1024 with built in cutting edge 1022, orby advancing any alternative cutting device over guide wire 1020, asshown in FIG. 66D, applicator 100 can be advanced over guide wire 1020and be manipulated into hole 986 in target vessel 984 by tilting itforward and backwards as described above, after removal of guide wire1020 or retracting it into the target vessel such that the free end ofguide wire 1026 that extends from the target vessel becomes locatedinside shoe 1030. Alternatively, a sharp, cutting edge 1022 may be builtinto wire insertion shoe 1030 to combine the creation of a controlledarteriotomy and insertion of applicator 100 in one movement.

Wire insertion shoe 1030 may also be equipped with a temporary lockmechanism 1034, such as shown in FIGS. 67C and 67D, to reversibly clampwire insertion shoe 1030 and applicator 100 to a specific spot on guidewire 1026 that extends from target vessel 984. This permits movement ofapplicator 100 back and forth by manipulating guide wire 1026. In thecase of a percutaneously introduced guide wire 1026, applicator 100 canbe drawn into target vessel 984 and positioned by manipulating guidewire 1026, thus adding the potential to remotely control the positioningof applicator 100.

One embodiment of such a lock is shown in FIGS. 67C and 67D. Channel1032 inside wire insertion shoe 1030 features a part with increaseddiameter, containing a short tube 1035, which can be pulled upwards bycable 1036 connecting wire insertion shoe 1030 to applicator 100. Guidewire 1026 is introduced through channel 1032 in wire insertion shoe 1030while tube 1035 with the connecting cable 1036 is relatively lax. Whenthe applicator 100 is at the desired spot on guide wire 1026, theconnecting cable 1036 is pulled, thereby moving the short tube 1035 to aposition eccentric to the central axis of the channel 1032, effectivelyclamping guide wire 1026. At the same time, wire insertion foot 1030 isrigidly connected to the front end of applicator 100. Releasing theconnecting cable can reverse the process. A temporary lock mechanism1034 may also be used in combination with a semi-axial introductionmethod.

Two Wire Technique

As shown in FIGS. 67A and 67B, wire insertion shoe 1030 features channel1032 for guide wire 1020 or 1026 as described above. In anotherembodiment shown in FIG. 67E, wire insertion shoe 1030 is not yetmounted on applicator 100, but instead is mounted on a guide rod 1024.Guidewire 1020 can be connected to shoe 130, and is preferably disposedat least partially within guide rod 1024. Shoe 1030 has a channel 1032extending lengthwise through shoe 1030 sized to accommodate guide wire1026. Preferably, a piece of flexible tubing 1028 extends from the toeof shoe 1030, and optionally, a cutting edge 1022 is used to help gainaccess to target vessel 984.

As shown in FIG. 67F, guide rod 1024 with shoe 1030 is advanced over thedistal end of guide wire 1026, which extends from target vessel 984,until wire insertion shoe 1030 is partially introduced into thearteriotomy in target vessel 984. The arteriotomy is preferably formedin a longitudinal direction relative to target vessel 984. Guide wire1026 is then pulled back into the target vessel or flexible tubing 1028to permit insertion of the heel of wire insertion shoe 1030 into thetarget vessel.

As shown in FIG. 67G, once shoe 1030 is disposed within target vessel984, guide wire 1026 can then be advanced again through channel 1032 ofinsertion shoe 1030 to capture insertion shoe 1030 within opening 986 oftarget vessel 984. As shown in FIG. 67H, guide rod 1024 is then removed,exposing second guide wire 1020 originating from the wire insertion shoe1030. As shown in FIG. 67I, applicator 100, now without any nosepiece,preloaded with graft 980 (not shown), is advanced over second guide wire1020. In situ wire insertion shoe 1030 is disposed at least partiallywithin opening 986 of target vessel 984. Protrusions 1025 extendproximally relative to second guidewire 1020 to assist in maintainingthe arteriotomy in the open position. In this way, applicator 100 may bepassed down guidewire 1020 to shoe 1030 from a position outside targetvessel 984 to a position whereat at least a distal portion of applicator100 is located within target vessel 984. In a preferred embodiment, shoe1030 includes male or female features 1021 that are configured to matewith male or female features 1023 located on a distal portion ofapplicator 100. In addition or alternatively, shoe 1030 can maintain aclear path for applicator 100 by pushing the longitudinal arteriotomy intarget vessel 984 open in a transverse direction from the inside, andapplicator 100 can simply be maneuvered to a position whereat applicator100 can be connected to shoe 1030.

Internal Mammary Artery

In one embodiment, graft vessel 980 can be the left or right internalmammary artery, commonly referred to as the IMA. The IMA can bedissected away from the chest wall and prepared for loading applicator100 therethrough. The length of the pedicalized IMA should be sufficientso that the distal end of the IMA can be positioned outside of the body(with the proximal end still attached) through a properly located port.In a preferred embodiment of the method, the port or opening is locatedintercostally, but may be located outside the rib cage or can be createdby removing part of a rib or by separating the ribs. Once the distal endof the IMA is located outside the body, guidewire 1020 can be insertedinto the opening of the IMA distal end and can be used to create anarteriotomy in the side of the IMA in a manner similar to that shown inFIG. 65D. Alternatively, the arteriotomy can be created using a separateinstrument from either the outer surface of the IMA or from the innersurface of the IMA via the open end.

The arteriotomy can be enlarged as described above using cutting edge1022 or some other device to make it easier to pass the distal end ofapplicator 100 through the arteriotomy and to better size thearteriotomy for the anastomosis, if required. Cutting edge 1022 can alsobe used to create an arteriotomy better suited for an anastomoses, suchas one having a more uniform appearance or having a particular shape.Alternatively, applicator 100 can be passed directly through thearteriotomy created by guidewire 1020. It is understood that, where aguidewire is said to create an arteriotomy, the guidewire may include acutting surface to create the opening or the guidewire may be used inconjunction with a separate cutting or coring instrument.

Once properly positioned within the IMA, guidewire 1020 can be removedfrom applicator 100, and applicator 100 can be passed back into thepatient's body through the port and positioned near a second arteriotomymade in target vessel 984 via a guidewire 1024 that extends from thearteriotomy. The second arteriotomy can be formed by guidewire 1024 thatenters target vessel 984 directly at the second arteriotomy site (inwhich case the second arteriotomy is created from outside the targetvessel 984 and into the interior of target vessel 984) or guidewire 1024can enter target vessel 984 from a location spaced from the secondarteriotomy (in which case the second arteriotomy is created from theinterior or lumen of target vessel 984 and passes through the outersurface of target vessel 984). In the latter case, guidewire 1024 canenter target vessel 984 via a peripheral vessel that communicates withthe target vessel or via the target vessel itself, at a position distalto the blockage or proximal to the blockage.

Applicator 100 can be loaded over guidewire 1024 through the same lumenvacated by guidewire 1020 or by a separate lumen formed in applicator100. Applicator 100 may be loaded over guidewire 1024 at a locationwithin the patient's body, but preferably applicator 100 is loaded overguidewire 1024 at a location outside the patient's body. In this way,the surgeon can load applicator 100 onto the graft vessel (an IMA) andthen onto guidewire 1024 at a location where he or she can visuallyconfirm the correct positioning. Following those steps, the surgeon canpass applicator 100 and graft vessel 980 down guidewire 1024 to the siteof the distal or target vessel arteriotomy, whereupon the distal end ofapplicator 100 can be positioned within target vessel 984. As discussedabove, applicator 100 is then manipulated to expand and compressconnector 200 to complete the anastomosis between target vessel 984 andgraft or bypass vessel 980. Applicator 100 and guidewire 1024 are thenremoved from the site, and, if needed, the distal end of the IMA isclosed using a clip, suture or other means.

In an alternative method, guidewire 1020 can be used as a guide tolocate the target vessel arteriotomy. In this case, once guidewire 1020is passed through the open end of graft vessel 980, guidewire 1020 canbe passed back into the patient's body through the port and then can beused to create an arteriotomy in the target vessel or simply to find thearteriotomy in the target vessel created by another means. In such acase, once the distal end of guidewire 1020 is disposed within targetvessel 984, the surgeon can pass applicator 100 and graft vessel 980distally along guidewire 1020 back into the patient's body via the portto the site of the distal or target vessel arteriotomy. As with theabove method, the surgeon then positions the distal end of applicator100 within target vessel 984, and manipulates applicator 100 to expandand compress connector 200 to complete the anastomosis between targetvessel 984 and graft or bypass vessel 980. Applicator 100 and guidewire1024 are then removed from the site, and, if needed, the distal end ofthe IMA is closed using a clip, suture or other means.

While the above anastomosis methods are described as being performed byapplicator 100, it is understood that any type of connector device couldused to perform the same method. Thus, for instance, a connector that isdeployed by a balloon could also be positioned at the distal site via aguidewire 1022 or 1024. In either case, the guidewire could be loadedover the connector deployment device at a location external to thepatient's body and then passed back to the location of the distalarteriotomy, where the balloon is passed through the distal arteriotomyand the connector deployed.

In one embodiment, a guidewire is passed via a peripheral artery intothe IMA. The IMA is accessed via a port, preferably intercostally,pedicalized and dissected to create an open end. The guidewire is pushedout the open end of the IMA and passed out the port along with thepedicalized IMA. A connector of the type incorporated by reference aboveis then loaded onto the IMA and/or connected to the IMA. The connectorscan include, for example, those depicted or described in U.S. Pat. No.6,485,496, U.S. patent application Ser. No. 09/708,617, InternationalPublished Patent Application No. WO 02/38055, or U.S. Patent PublicationNo. 2003/0045902, or an adhesive or nitinol clips, or any combination ofthe above or any other connector known to one skilled in the art. Asdescribed above, the connector and graft vessel are then passed over aguidewire that marks the location of the distal arteriotomy, back intothe patient's body via the port, and distally along the guidewire untilthe connector and graft vessel are proximate the distal arteriotomy. Atthis stage, the connector is deployed using any method known to thoseskilled in the art to complete the anastomosis. Where the guidewire wasplaced peripherally, it may be removed by withdrawing it proximally viathe peripheral vessel.

In an alternative embodiment, a guidewire is passed via a first portfrom outside the patient's body into a side branch of the IMA and intothe IMA. As above, the IMA is then pedicalized and dissected (preferablyfrom the first port, but possibly a second port) to form an open end. Asdescribed above, the connector is loaded onto the IMA outside thepatient's body and passed back in via the port through which it had beenremoved. The connector is deployed to form the anastomosis, at whichpoint the guidewire can be removed from the side branch of the IMA outthe first port, unless it was removed at an earlier step in the method.The side branch of the IMA is then closed via a suture or clip or othermethod, and the port or ports are closed.

Alternatively, the IMA can be pedicalized and dissected and theguidewire can be passed through the open end of the IMA, passed out adissected side branch of the IMA and then passed through a port. Theopen end of the IMA can be pulled outside a port to load a connectoronto the open end either before or after passing the guidewire throughthe open end. Similar to the above method, the guidewire is then passedinto an opening formed in the target artery and the IMA is guided viathe guidewire to the anastomosis site. The connector is deployed to formthe anastomosis, at which point the guidewire can be removed from theside branch of the IMA via the port, unless the guidewire was removedprior to deploying the connector. The side branch of the IMA is thenclosed via a suture or clip or other method, and the port or ports areclosed.

While the anastomosis method described above uses an IMA (either rightor left) as the bypass or graft vessel, the surgeon could use thegastro-epiploic or axillary artery in the same manner; i.e., free thevessel from internal tissue and position the distal end of the vesseloutside the body (with the proximal end still attached) through aproperly located port. In the alternative, the surgeon could use abranch of an IMA rather than the IMA, itself, to perform the procedure.

Finally, the surgeon may harvest a saphenous vein or radial artery orother vessel, or may use a synthetic or animal vessel as a bypassvessel. In such a case, the surgeon can anastomose one end of such abypass vessel proximally to the aorta or distally to the blockedcoronary artery using a connector or suture and then position the freeend of the bypass vessel outside the body through a properly locatedport or opening. At this stage of the procedure, applicator 100 can bepassed through the free or open end and out an arteriotomy formed in thebypass vessel in the manner described above, preferably over aguidewire. Alternatively, a connector can be attached to the free end ofthe graft. In this way, even a typical bypass procedure using asaphenous vein or the like can be conducted in a minimally invasivemanner using a port or opening in the patient to access the free end ofthe graft vessel and load the connector or applicator over the free endat a position outside the patient's body. As described above, the freeend of the bypass vessel, along with the applicator and/or the connectoris then passed back through the port or opening into the patient's bodyand the anastomosis is completed.

Protective Rings

An anastomosis between the graft vessel and the target vessel, may bemechanically protected by an external protective ring 1100, as depictedin FIGS. 68 a-68 d. In positions susceptible to direct trauma,particularly the abdomen and limbs, potential permanent deformation ordestruction of the expanded connector may result, which might obstructthe anastomosis. An additional external structure, like protective ring1100, may be provided. Protective ring 1100 may have any suitable shapeincluding, but not limited to, spherical, polygonal, elliptical,toroidal, and U-shaped. Protective ring 1100 is provided with a centralhole or cavity 1112, which is large enough to fit around theanastomosis, and also provides an easy, unobstructed entry and exit forthe joined vessels to the central hole 1112, for example, viaindentations 1114. Protective ring 1100 protects the anastomosis byabsorbing or deflecting forces that may cause trauma, thus improving thelong-term safety and durability of the device. Protective ring 1100 maybe made of one piece, in which case it should generally be brought intoplace before or during construction of the anastomosis, or may be madeof several, interlocking pieces, in which case the ring can be placedafter completion of the anastomosis. Besides protection, protective ring1100 may have, but need not have, hemostatic functionality that can beprovided by mechanically sealing the anastomotic line from the outside,or by coating protective ring 1100 on its inner surface, at least in theareas near or in contact with the anastomotic line, with one or morehemostatic substances for accelerating clot formation. Also, protectivering 1100 may be used as a matrix for the addition of biocompatibleglue, to reinforce the anastomosis, to repair leaks or remedy oozingblood.

One embodiment, suitable for application after creation of theanastomosis with connector 200, is shown in FIG. 68 a, which depictsexternal protective ring 1100 in an open position. External protectivering 1100 has two interlocking halves 1102, 1104. First anastomotic ringhalf 1102 and second anastomotic ring half 1104 are connected by hingeportion 1106. First anastomotic ring half 1102 and second anastomoticring half 1104 are locked around a completed internal side-to-sideanastomosis, after checking for hemostasis, by placing ring half 1104,for example, about one side of the anastomosis and pivoting ring half1106 about the other side of the anastomosis, and then snapping togetheranastomotic ring locking portion 1108. External protective ring 1100 ispreferably constructed of a stiff type of plastic (e.g. hardpolypropylene), however it can be made of other materials.

FIG. 68 b shows external protective ring 1100 placed around graft 1112,which is a completed internal side-to-side anastomosis, although it canbe placed around other grafts as well and used in other procedures, suchas, but not limited to, peripheral vascular surgery (fem-pop bypasses),intra-abdominal vascular procedures, hemo-dialysis shunt construction,and tissue auto transplantations in plastic surgery. First anastomoticring half 1102 and second anastomotic ring half 1104 are locked aroundgraft 1112, under graft clip 1110.

The surface of external protective ring 1100 may be roughened to improvetissue ingrowth, in order to better deflect forces from the anastomosisto surrounding tissue. The shape of external protective ring 1100 isadapted to accommodate graft 1112, having a saddle like indentation1114. To accommodate a jump graft, two opposite indentations may bedesirable. External protective ring 1100 can be deployed with standardinstruments like a forceps, or preferably by a dedicated tool (like amodified clip applier).

FIG. 68 d shows a partially open external protective ring 1116,integrated with graft clip 1110. Partially open external protective ring1116 has a lock for securing the closure of graft clip 1110 (such as theAbsolok® PDS clip). Wings 1118 make up the body of partially openexternal anastomotic ring 1116 and protect graft 1112 in a way similarto external protective ring 1100.

It will be understood that specific elements of the various methodsdescribed above, can be combined at will to suit specific purposes orsituations. Also, as already indicated, with only slight modifications,the described methods are also applicable to true end-to-side andend-to-end anastomoses.

Certain embodiments of the device of the present invention are suitablefor closed chest CABG procedures wherein a guide wire pierces theblocked coronary artery distal to the blockage and is extended somedistance from the heart. The wire may then be inserted inside thecentral hole in the applicator. The device may then be advanced over theguide wire and thus follows the guide wire to the location of theanastomosis. The graft would have to be loaded onto the device beforefollowing the guide wire but this would not interfere with the functionof the guide wire.

The foregoing detailed description of the various embodiments of theinvention has been provided for the purpose of illustration anddescription only and is not to be construed as limiting the scope of theinvention in any way. The scope of the invention is to be determinedfrom the claims appended hereto.

1. A method for performing a coronary artery bypass graft procedure on apatient to connect a bypass vessel to a target vessel, comprising thesteps of: creating an opening in the patient that communicates with thethoracic cavity of the patient; providing a bypass vessel having a lumenand at least one free end; passing the free end of the bypass vesselfrom the thoracic cavity through the opening to a position outside thebody of the patient; attaching a connector to the free end of bypassvessel while the free end of the bypass vessel is outside the body ofthe patient; passing the free end of the bypass vessel from the positionoutside the body of the patient through the opening and into thethoracic cavity; and connecting the free end of the bypass vessel to atarget vessel with the connector.
 2. The method of claim 1, wherein thegraft vessel is an internal mammary artery and comprising the step ofcutting the internal mammary artery to provide the free end.
 3. Themethod of claim 2, comprising the step of creating an arteriotomy in aside of the graft vessel at a location proximal of the free end.
 4. Themethod of claim 3, wherein the step of creating an arteriotomy comprisesinserting a guidewire into the lumen of the free end.
 5. The method ofclaim 4, wherein the step of creating an arteriotomy comprises incisingthe side of the graft vessel with the guidewire.
 6. The method of claim3, comprising the step of passing at least the distal end of anapplicator having an anastomotic device carried thereon through thelumen and the arteriotomy.
 7. The method of claim 6, wherein the passingstep of claim 6 comprises passing the applicator over a guidewire thatis positioned through the lumen of the graft vessel, with one end of theguidewire passing through the arteriotomy and the other end of theguidewire passing through the free end of the graft vessel.
 8. Themethod of claim 7, comprising the step of creating a target vesselarteriotomy in a wall of a target vessel.
 9. The method of claim 8,comprising the step of positioning the guidewire through the targetvessel arteriotomy and into the target vessel lumen.
 10. The method ofclaim 9, comprising the step of passing at least the distal end of theapplicator over the guidewire toward the target vessel arteriotomy. 11.The method of claim 10, comprising the step of passing at least thedistal end of the applicator into the target vessel arteriotomy.
 12. Themethod of claim 11, comprising the step of actuating the applicator toconnect the connector to at least the target vessel.
 13. The method ofclaim 12, wherein the step of actuating comprises actuating theapplicator to connect the connector to the target vessel and the graftvessel.
 14. The method of claim 1, comprising the step of forming atarget arteriotomy in a wall of a target vessel.
 15. The method of claim14, comprising the step of passing at least a distal end of a secondguidewire through the target arteriotomy from a position within thetarget artery to position outside the target artery.
 16. The method ofclaim 14, comprising the step of passing at least a distal end of asecond guidewire through the target arteriotomy from a position outsidethe target artery to position inside the target artery.
 17. The methodof claim 14, comprising the step of positioning at least the distal endof an applicator having an anastomotic device carried thereon within thelumen of the graft vessel, guiding the distal end of the graft vesselover a second guidewire positioned within the target vessel arteriotomyto a position where at least the distal end of the applicator is withinthe target vessel arteriotomy, and actuating the applicator to connectthe connector to at least the target vessel.
 18. The method of claim 1,wherein the opening is one of an intercostal opening and an opening islocated outside the thoracic cavity.
 19. The method of claim 1, whereinthe graft vessel is one of a vein, artery, synthetic and animal vessel.20. The method of claim 1, wherein the step of connecting comprisesdeforming the connector to compress a portion of the graft vessel and aportion of the target vessel such that the lumen of the graft vesselcommunicates with the lumen of the target vessel.